Job Search Results for biotech

One of our large biopharmaceutical clients is seeking a CSV specialist to join their team for a Windows 11 upgrade. This role focuses on assessing system impact, executing validation deliverables,... More coordinating with the DeltaV and MES team to ensuring that all upgraded platforms meet regulatory, data integrity, and business continuity requirements. The ideal candidate brings deep experience in Computer System Validation (CSV) within a regulated biopharmaceutical environment and is comfortable working at the intersection of IT infrastructure and GMP operations.Key ResponsibilitiesWork on CSV activities related to the Windows 11 operating system upgrade across GxP-impacted systems and applications.Perform system impact assessments, risk evaluations, and gap analyses to determine validation scope.Develop and execute validation documentation, including URS, FRS, RTM, IQ/OQ/PQ, and validation summary reports.Partner with IT, Quality Assurance, and system owners to ensure compliant implementation and smooth transition of validated systems.Review vendor documentation and assess suitability for GMP use.Ensure all changes follow change control, deviation management, and data integrity requirements.Support testing activities, including regression testing, functional verification, and system compatibility checks.Maintain clear documentation and traceability throughout the validation lifecycle.Provide guidance on regulatory expectations related to OS upgrades, cybersecurity, and system lifecycle management.Support audits and inspections by providing validation evidence and subject-matter expertise.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

Day to Day: Our client is searching for a Capital Projects Sourcing Manager, who will have an opportunity to work closely with many different business functions and construction and equipment spend... More categories in one of the leading Biotech companies in the world. They will understand how large multi-national companies work and how to work within a matrixed corporate environment. Preference for this individual to sit locally and come to the site 2 days per week, however open to remote with twice per year travel to the site. virtual onboarding and training,. Primary responsibilities include the following:?Assigned to a portfolio of large capital projects valued at $500 million+ each and potentially a number of medium capital projects in a $25 to $100 million range?Provide support to a variety of spend sub-categories including Architectural and Engineering services, Construction Management services, Automation Integration services, Commissioning, Quality and Validation services, and General Construction Contractor and individual Construction Trade Services?Serve as the Contracting lead, responsible for determining the contracting strategy, including selecting appropriate contract template, negotiations and contract creation in Sirion, managing ongoing contract management needs and to be accountable for hand-off to Contract-to-Pay teams?Execute and implement the sourcing strategy and purchasing needs of Amgen?s US based spend across the Operations organization?Execute e-sourcing (eRFX) for the Capital Construction and Capital Equipment Global Category Management (GCM) teams?Be the Procurement Process and Systems expert ensuring compliance with all relevant global sourcing policies and procedures, and participate as an integral member of Project Delivery teams Delivering Value for Business Partners:?Understands business goals and customer needs to implement opportunities while providing training and guidance?Partners with colleagues in Finance and all other Function Heads as appropriate?Supports / Manages delivery and validation of savings for Global Category Managers?Anticipates and prevents potential problems through root cause analysis Managing Capital Projects and Contracts?Draft and ensure timely reviews and execution of all Contract documents using Sirion; work closely with Lega to progress contract language and agreement?Support ongoing contract management (incl. renewing and renegotiating existing and expiring contracts)?Ensure procurement policies are followed, and that compliance metrics are met or exceeded, supported through supplier contracts published in AribaWe are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

Insight Global is looking for an Associate Project Manager (APM) who will provide both task-based assignments and, under supervision, support limited project level management for capital projects and... More initiatives, from conceptualization through design, bidding, construction, commissioning, and close out. The Associate Project Manager shall effectively complete all assigned project assignments, take direction from supervisor(s) on soft projects and department initiatives associated with the engineering, design, and construction department goals. Using project management tools and techniques, the Associate Project Manager shall coordinate project scope, schedule and budget requirements with the Planning and Operations departments, design consultants and Contractors. With guidance and direction from supervisors, the Associate Project Manager will lead projects of diverse scope requiring an understanding of current business trends, construction techniques, innovative project delivery methods, thorough knowledge of HVAC, electrical, plumbing, fire protection, core and shell construction as well as rigor in compliance, and the highest standard of care. A self-starting, achievement-oriented focus that fosters a productive team environment while driving projects to successful completion is essential. This is a 12 month contract with potential to extend, 4 days onsite in Tarrytown, NY with a pay rate around 53/hr.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

BD is hiring a hands-on Industrial Engineer to drive process improvements across a regulated manufacturing environment. This role focuses on improving efficiency, throughput, and quality while... More partnering with operations, quality, and supply chain teams.?Lead process improvement and lean initiatives?Improve production flow, throughput, and quality?Design layouts and optimize material flow (AutoCAD/SolidWorks)?Own SAP data (BOMs, routings, capacity)?Support scheduling and capacity planning?Lead cost savings and productivity projects?Run time studies and analyze process performance?Support FMEA, CAPA, and root cause analysis?Drive Kaizen and continuous improvement efforts?Work cross-functionally with ops, quality, and engineering?Create and update SOPs, work instructions, and documentation?Troubleshoot production issues and train operatorsWe are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

One of our large biopharmaceutical clients is seeking a CSV specialist to join their team for a Windows 11 upgrade. This role focuses on assessing system impact, executing validation deliverables,... More coordinating with IT and Quality, and ensuring that all upgraded platforms meet regulatory, data integrity, and business continuity requirements. The ideal candidate brings deep experience in Computer System Validation (CSV) within a regulated biopharmaceutical environment and is comfortable working at the intersection of IT infrastructure and GMP operations.Key ResponsibilitiesWork on CSV activities related to the Windows 11 operating system upgrade across GxP-impacted systems and applications.Perform system impact assessments, risk evaluations, and gap analyses to determine validation scope.Develop and execute validation documentation, including URS, FRS, RTM, IQ/OQ/PQ, and validation summary reports.Partner with IT, Quality Assurance, and system owners to ensure compliant implementation and smooth transition of validated systems.Review vendor documentation and assess suitability for GMP use.Ensure all changes follow change control, deviation management, and data integrity requirements.Support testing activities, including regression testing, functional verification, and system compatibility checks.Maintain clear documentation and traceability throughout the validation lifecycle.Provide guidance on regulatory expectations related to OS upgrades, cybersecurity, and system lifecycle management.Support audits and inspections by providing validation evidence and subject-matter expertise.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

One of our large pharmaceutical clients is looking to hire an Associate Scientist of Cell Banking to perform Cell Banking for the Cell Culture processes and/or bio-analytical testing within the API... More Large Molecule Process Development group in Malvern PA. The candidate's primary responsibilities will include but are not limited to the production, testing, inventory, and supply of Master, Working, and development Cell Banks for clinical, and commercial production as well as analytical testing for biopharmaceutical and cell therapy products. Responsibilities will include: -Support Cell banking organization by performing Cell banking for Cell Culture processes and analytical testing. -Execute production, testing, and release of Master, Working, development, and analytical cell Banks and ensures the timely supply to customers. -Work in a team environment as well as contributing individually to meet project timeline and objectives. -Participate in Cell culture and cryopreservation of cells using aseptic techniques under GMP Compliant conditions. -Execute all activities per established procedures and protocols -Interface with internal and external customers to ship cell banks and supply critical information as per their requirements. -Collaborate cross-functionally to represent Cell Banking department. -Author, review, and approve technical documents, SOPs, and batch records.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

Insight Global is seeking Production Operators to support aseptic manufacturing operations on our pharmaceutical client's 1st and 2nd shift operations. This individual will work in a controlled... More cleanroom environment, contributing to fill/finish operations and supporting the setup, operation, and basic troubleshooting of equipment within classified production areas (A/B, C, D).Responsibilities include operating and maintaining equipment such as the stopper processor, vial washer, tunnel, capper, filler, autoclaves, VHP pass-thru, small parts washer/dryer, and lyophilizer. The role also involves identifying and resolving minor mechanical issues to ensure consistent production performance.The ideal candidate will uphold strict adherence to GMP and aseptic processing standards while maintaining a strong focus on quality and compliance. This is an excellent opportunity for individuals looking to build a long-term career in pharmaceutical manufacturing and gain hands-on experience in aseptic operations.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

The Clean Room Specialist is responsible for maintaining a controlled, contamination-free environment in accordance with industry standards and organizational protocols. This role ensures compliance... More with cleanliness, safety, and operational procedures to support manufacturing, laboratory, or healthcare processes.Responsibilities:a. Maintain and monitor cleanroom conditions (e.g., temperature, humidity, particle counts). Work on improvements to ENSURE compliance.b. Follow strict gowning procedures and ensure compliance by all personnel entering the cleanroom.c. Perform routine cleaning and sanitation of cleanroom surfaces, equipment, and tools using approved methods.d. Operate within ISO classification standards and adhere to regulatory requirements (e.g., GMP, FDA guidelines).e. Conduct inspections and audits to ensure cleanroom compliance and identify contamination risks.f. Document activities, logs, and deviations in accordance with quality standards.g. Handle materials and equipment using contamination control techniques.h. Assist in troubleshooting contamination issues and implementing corrective actions.Support production, laboratory, or technical teams in a cleanroom environment.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

One of Insight Global?s pharma clients based out of Boston, MA is seeking a Project Manager to join the Commercial IT organization. This role reports directly to the Director and is responsible for... More end to end execution and delivery of projects across the Commercial portfolio.The Project Manager will lead initiatives spanning Field Enablement, Master Data Management, Customer Engagement, and Analytics, supporting both new disease area launches and enhancements to existing commercial programs. The role requires hands on ownership of project delivery from initiation through launch, with strong day to day execution, risk management, and executive level status reporting.Key Responsibilities?Drive end to end project execution from initiation through launch across Commercial DTE initiatives?Create and manage all project deliverables, including: oProject chartersoDetailed project plans and schedulesoStage gates and milestonesoStatus reporting and dashboards?Manage and track project execution across all workstreams, including: oTask ownership, dependencies, and timelinesoCross functional coordination across business and technology teamsoProactive identification of risks, issues, and resource constraints?Own and maintain the RAID log (Risks, Actions, Issues, Decisions), ensuring: oClear documentation of decisionsoTimely completion of actionsoProper escalation and communication of risks and issues?Partner with implementation teams to manage JIRA using Agile and/or Waterfall methodologies?Deliver weekly project status reports in the agreed client format, tailoring communication for: oDay to day delivery teamsoBusiness stakeholdersoSenior leadership and executives?Collaborate closely with delivery partners, software vendors, and internal DTE and business stakeholders to ensure successful outcomes?Ensure alignment and dependency management across interconnected projects and programs within the Commercial portfolio$75-80/hrWe are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

Key Responsibilities?Curriculum Transformation: Deconstruct the current multi-week in-person curriculum and redesign it into a sophisticated blended learning journey including vILT, self-paced... More eLearning, and remote hands-on practice.?Virtual Instruction Strategy: Design interactive virtual classroom experiences for complex, software-driven technical skills, including CT image interpretation and 3D modeling applications.?Technical Software Training Enablement: Translate hands-on, expert-led training for complex 3D and analytical software into scalable virtual learning experiences that maintain accuracy, speed, and decision quality.?Stakeholder Collaboration: Partner with Subject Matter Experts (SMEs) and Technical Trainers to translate highly regulated FDA/ISO-compliant procedures into digestible, instructor-led and digital content.?Content Development: Create high-quality instructional assets including facilitator guides, interactive storyboards, simulation-based assessments, and technical job aids focused on software proficiency and applied decision-making.?LMS Management: Integrate new modules into the Learning Management System (LMS) and ensure seamless tracking of learner progress and competency benchmarks.?Measurement & Evaluation: Define success metrics to ensure the virtual program maintains or exceeds the efficiency and quality standards of the legacy in-person model using Kirkpatrick Levels 1?4.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less