Reporting to the Director of Technical Services, the Sr. Process Engineer position is responsible for leading the development of pilot and full-scale manufacturing processes for skincare, personal care, and color cosmetic products. This position is also responsible for state of validation for equipment, processes, facility and cleaning of OTC manufacture and production. The Sr. Process Engineer will supervise a Jr. Engineer dedicated to validation activities.
Essential Functions for Sr. Process Engineer:
- Develop and revise manufacturing processes related to internal and external formula transfers
- Evaluate and recommend new processing equipment & systems for bulk manufacturing to ensure continued sophistication and improvement in the manufacturing department
- Review, plan, schedule and organize new & existing validation projects including manufacturing and filling equipment, manufacturing and filling processes, plant systems, storage facilities and cleansing & sanitization processes.
- Design IQ/OQ/PQ and validation campaigns, develop and prepare protocols for process validation
- Coordinate validation and IQ/OQ/PQ activities with manufacture, production, sanitization, quality control and outside testing facilities providing leadership, guidance, and training.
- Review and analyze analytical, microbiological, and physical data generated from validation activities.
- Write validation final reports that present, summarize, and offer conclusions on the validity of the processes based on findings and obtain necessary approvals on a timely basis.
- Work with Manufacturing and Production to generate Failure Mode & Effects Analysis (FMEA) and risk assessment of new projects.
Sr. Process Engineer Qualifications
- Bachelor’s degree in a scientific discipline (Engineering, Biology, Chemistry)
- 3+ year experience in process engineering and process validation preferably in the regulated Personal Care industry
- Familiar with CAPAs, Change Controls, audits & investigations
- Must be able work in a fast-paced environment and to think critically & analytically (“Think outside the box”)