Our Consumer Manufacturing Client is seeking a Remote Manufacturing Process Engineer to join their MS&T department to provide technical support to commercial, solid, liquid, and/or semi-solid pharmaceutical products, dietary supplements, new products in development, and technology transfer activities. They will engage in formulation and process development activities, characterization, process performance qualification, and continued process verification supporting the External Manufacturing network for Self Care OTC franchises. The incumbent will ensure quality and compliance in all cGMP related activities, maintain all required training for the role, and follow standard operating procedures to complete the required work. The Manufacturing Process Engineer will * Design and complete experiments/deliverables at small and large/commercial scale to support project objectives that supports base business. Project tasks may include sample collection, in process testing, sample management, data analysis, etc. They will prepare or approve technical memos or reports by analyzing data, developing conclusions and recommendations based on sound scientific principles. Their commercial business support will include: change control deliverables/documentation, investigations, CAPAs, and APR data collection, analysis and review/approval. Write and/or approve standard operating procedures or provide input to SOPs, policies, and standards. They will partner with cross-functional peer group and management and participate as a technical team member or technical representative on cross functional teams. They will provide technical troubleshooting and recommendations using knowledge, experience, data analysis, and problem-solving tools to address sophisticated technical problems that may have a direct impact on commercial product quality or supply. May also prepare, review, or approve regulatory documents (e.g. related to NDA, ANDA, or SNDA).
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- Bachelor's of Science degree or equivalent in Engineering, Chemistry, Pharmacy, etc.
- Manufacturing Experience
- Knowledge of GMPs, ICH, CFR
- Experience in processes such as scale-up, process validation, product/process technical transfer, or product life cycle management/continued process verification
- Solid understanding of scientific principles for liquid/semi-solid formulation development (i.e., solution, suspension, semi-solid), solid dosage development (i.e., immediate and delayed-release), and/or other formulation development (i.e., Nasal Spray, Eye drops, Lozenges, and sterile products) in support of scale-up and technology transfer
- Strong process knowledge in liquid and/or solid dose such as mixing, filling, granulation, compression, and/or film-coating
- Knowledge and understanding of sampling requirements and the collection and evaluation of data, from the process design stage through commercial production
- Excellent Communication Skills
- Proficient in MS Office applications and data-based documentation and knowledge management systems
- Knowledge in statistical software, statistical process control, and statistical analysis of experimental data
- Comfortable traveling 20%, primarily North America
- Pharmaceutical Manufacturing experience
Benefit packages for this role will start on the 31st 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.