Process Engineer – Pharmaceutical Technology (R-PDPE)
Department: Process Development
Location: Rochester, Michigan
In partnership with the site leaders sponsors a quality and compliance focused site culture which embraces RFT (right first time) and CI (continuous improvement) expectations. Evaluates and performs specified validations leading to the accurate and reliable validation of equipment, facilities, and systems; assists/performs development of cycles for new processes; helps troubleshoot product problems related to validation; performs testing and documents results for review by site, corporate and government review.
Responsible for familiarity with specified equipment in order to comprehensively explain their function and design. Further responsible for providing supporting protocol rationales/justifications for the chosen validation methodology/approach.
The essential duties/competencies for this position include but are not limited to:
- Establishes and Maintains Effective cross functional relationships.
- Designs, implements validation protocols, and summarizes studies to ensure consistency of data production and compliance with manufacturer and MCP Pharmaceutical’s specifications, with current Good Manufacturing Practices, and national standards.
- Responsible for the performance qualification of production processes, and writes process validation protocols and final packages. Generates, executes and summaries Product Process Qualification for the entire scope of the production processes. Comprehensive understanding of all production processing steps and through knowledge of required validations.
- Issues data, memos and reports concerning validations projects.
- Develops validation protocols, performs testing and writes validation reports for various utilities, systems and equipment.
- Evaluates equipment or process problems and designs testing to determine possible causes or solutions; determines process capability of new equipment and assures defined parameters are incorporated into respective operating procedures and batch card records.
- Capable of providing reliable direction to Level I Validation Engineers concerning protocol execution practices and execution.
- Provides validation input at new product/process team meetings.
- Interacts with outside testing laboratories and provides validation assistance where needed on specific validation issues
Education / Qualifications / Certifications:
- BS, MS, or PhD in a science related field (Chemistry, Engineering, Pharmacy desired), with five to ten years’ experience and or training; or equivalent combination of education and experience.
If you possess the required background and are interested in being a member of this growing company, submit your resume and cover letter online:
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