Job Description

Apex Systems has partnered with a leading CDMO company to fill a Validation Engineer position in their Grafton, WI site.

Ideal candidates will come from a Quality Engineering background and/or possess a chemical engineering degree. Candidates MUST be familiar with GMPs. The main task will be writing and validating IQOQ’s.

If interested, please apply with an updated resume.

Job Title: Validation Engineer

Location: Grafton, WI

Onsite: 5 days per week

Duration: 6-9 month contract

Summary: The Validation Engineer is responsible for managing all technical aspects of assigned products and/or new processes in manufacturing. This includes writing and validating IQOQs, preparing batch log records and cleaning log records, supporting production, conducting investigations, implementing corrective actions, and improving yields and cycle times.

Essential Duties, Responsibilities, and Accountabilities:

• Collaborate closely with Engineering and Chemical Development departments for equipment validation.
• Validate new equipment according to approved testing plans and report results accordingly.
• Develop and write GMO qualifications for new pharmaceutical equipment using templates.
• Adhere to personal moral, ethical, legal, and behavioral conduct in compliance with the Code of Conduct.
• Implement and adhere to all applicable SHE, DEA, and cGMP regulations.
• Familiarity with equipment specification and qualification, deviations, CRs, MBRs, IQOQs, writing procedures, Visalia, and Blue Mountain maintenance system is a plus.

Education and Experience:

• A 4-year degree in Chemical Engineering is desired, along with 1-5 years of hands-on experience in a pharmaceutical or fine chemical batch plant.
• Experience with Drug Substance/API Pharma processing equipment.
• Ability to review and summarize data from equipment validation studies and write summary reports for Quality approval.

Other Requirements:

• Excellent verbal and written communication skills.
• Highly conscientious and detail-oriented.
• Ability to work efficiently with people of all levels and cultures.
• Team player.
• Self-starter and initiator.
• Ability to manage projects and prioritize appropriately.
• Knowledge of organic chemistry.
• Knowledge of standard process equipment.
• Excellent computer skills (MS Office).

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