Job Description
• Provide validation & technical support through the preparation, execution, data analysis, & report writing for IV, OV & PV protocols
• Ownership of Change Requests (CR’s) related to project validation responsibilities
• Perform compliance & technical reviews/approvals of protocols & protocol data
• Author project quality masterplans (PQMP’s), validation plans (VPL’s), & other key validation documentation
• Author & execute assigned IV, OV & PV protocols for direct impact systems/processes per approved timeframes. Requires no guidance & direction to complete these goals & needs no coaching on technical competencies for goal obtainment. Serves as a source of expertise in the group for validating new systems
• Ensure compliance of validation protocols executed are aligned with local, corporate & regulatory regulations
• Lead validation failure investigations & non-conformities utilizing root cause analysis techniques
• Create & modify existing validation procedures & configuration item lists (CIL’s) as required
• Write/Review specifications, procedures, & other required supporting documents to maintain the validated state of equipment & processes
• Participate in FAT, SAT commissioning efforts for equipment, automation systems & processes & successfully transition into the ownership role for validation efforts related to the equipment
• Identify process improvements before equipment, systems or processes are placed under change control during validation
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/.
Required Skills & Experience
• Bachelor's Degree in Engineering, Computer Science, or applicable technical degree or proven equivalent relevant work experience required
• Master's Degree preferred
• Minimum of seven (7) years validation or quality related discipline experience in pharmaceutical environment required
• Assembly and Packaging experience
Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.