Quality Engineer

• Responsible for reviewing weekly system releases.
• Oversees engineering change controls (ECR) for critical equipment and controlled areas which include preapproval and post approval of change controls.
• Provides support to the plant during operational run times as well as during maintenance shutdown activities both of which include off shift coverage.
• Provides quality oversight for software validation, equipment qualification, and facility commissioning and validation. Drafts, and reviews validation documentation for critical systems and equipment.
• Troubleshoots problems related to critical systems and equipment (Water, HVAC, Pest Control, Lyophilizers, Vial Washers, etc). Analyzes data and implements both corrective and preventative actions to enhance processes.
• Analyzes data, conducts root cause investigations, performs gap analyses and risk assessments, develops corrective or preventive actions, and implements procedural and physical changes to reduce defects, improve efficiencies, and ensure compliance with all regulatory requirements, e.g., cGMPs, FDA Guidelines, USP, ISPE, ISO etc.
• Proactively takes ownership of quality processes and implements solutions in support of continuous improvement.
• Works with Engineering & Maintenance to identify possible trends in FMS and review impact.
• Develops, red-lines, reviews, and/or implements quality documents related to critical systems, processes and equipment.
• Conducts internal audits of all critical systems, processes and equipment, as well as the quality processes that oversee them, and identifies gaps in compliance and opportunities for improvement.

Requirements

• B.S. degree in a technical science is required. Engineering degree is highly preferred.
• 3 years experience in a highly regulated industry required.
• 3 years experience in the pharmaceutical industry highly preferred.
• 3 years experience in change control preferred.
• Working knowledge of aseptic processing is highly preferred.
• Working knowledge of cGMP practices to include 21 CFR Part 210, 211 and Part11, Electronic Records, USP, ISO 13485 and 14644, and ISPE trends and guidelines.
• CQE or CSSGB is a plus.
• Experience with Trackwise and EDMS preferred.

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.