Company/Role Overview:
CliftonLarsonAllen (CLA) Search has been retained by Optima Machinery Corporation for their Pharma Division to identify Qualification Engineers to serve their team. With locations and customers all over the world, Optima Machinery Corporation designs and builds packaging and filling machines including complete production lines for pharmaceutical, consumer, nonwovens and life science products.
The CQV Engineer ensures that pharmaceutical manufacturing systems, facilities, and equipment meet design specifications and regulatory standards. This role involves developing and executing commissioning, qualification, and validation protocols to ensure compliance with Good Manufacturing Practices (GMP).
This job is fully remote and can be based anywhere in the U.S. Travel to Optima Machinery Corporation locations in Raleigh, NC, Green Bay, WI, and Germany will be required.
To learn more, click here: https://www.optima-packaging.com/en.
What You’ll Do:
- Develop and execute commissioning protocols for new and existing equipment and systems, including Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).
- Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing and packaging equipment, utilities, and facilities.
- Conduct process, cleaning, and computer systems validation to ensure consistent and reproducible results.
- Prepare and maintain comprehensive documentation, including validation plans, protocols, reports, and traceability matrices. Managing the C&Q documentation and execution lifecycle from SLIA generation to OQ completion.
- Ensure all activities comply with regulatory requirements, including FDA, EMA, and other relevant guidelines.
- Participate in risk assessments and develop mitigation strategies to address potential validation issues.
- Identify opportunities for process improvements and implement changes to enhance efficiency and compliance.
- Work closely with cross-functional teams, including Quality Assurance, Manufacturing, Engineering, and Regulatory Affairs. Provide cGMP leadership and guidance while delivering CQV services.
What You’ll Need:
- Bachelor’s degree in Engineering, Life Sciences, or a related field.
- Minimum of 3 years of experience in commissioning, qualification, and validation within an FDA-regulated industry
- Experience in facilities and equipment startup, walk-downs and troubleshooting, FAT/SAT, URS, design review, P&IDs, IQ/OQ/PQs, generation, execution, etc.
- Strong understanding of GMP, FDA regulations, and industry standards. Proficient in life science manufacturing processes in biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy, or equivalent experience.
- Excellent problem-solving, analytical, and technical writing skills.
- Proficiency in using validation software and tools.
- Relevant certifications (e.g., ASQ Certified Quality Engineer) are a plus.
