Validation Engineer

Job description

Validation Engineer
Kenosha, WI
Competitive Pay and Benefits
The **Validation Engineer** will be responsible for supporting Commissioning, Qualification, and Validation (CQV) efforts within the Pharmaceutical and Life Sciences sectors. This position plays a critical role in ensuring that projects adhere to safety, compliance, and quality regulations. The ideal candidate will possess significant knowledge of GMP practices and will exhibit strong communication, technical, and organizational abilities.

Validation Engineer Responsibilities:

• Conduct Commissioning, Qualification, and Validation (CQV) procedures with a primary emphasis on safety.
• Ensure timely delivery of Commissioning and Qualification (C&Q) activities in accordance with project timelines.
• Monitor and report on the progress and key milestones of CQV activities.

• Create, evaluate, and update CQV documentation, including Standard Operating Procedures (SOPs), validation protocols, and master plans.
• Assist with the qualifications of equipment design and the preparation of regulatory compliance documents.
• Guarantee compliance with industry standards and GMP requirements.

• Plan for necessary spares, consumables, and resources for commissioning activities.
• Distribute project resources to ensure smooth execution of tasks.
• Facilitate coordination among internal teams and manage logistics during CQV execution.

• Carry out and assist with Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs), design evaluations, equipment shake-downs, and IQ/OQ/PQ testing.
• Collaborate with contractors and vendors to arrange validation and testing procedures.

Validation Engineer Requirements:

• Bachelor’s degree in Engineering, Chemistry, Life Sciences, or a related discipline (or corresponding professional experience).
• At least 2 years of experience within the Pharmaceutical or Life Sciences field.
• Knowledge of GMP-compliant environments and relevant regulatory standards.
• Exceptional written and verbal communication skills.
• Strong analytical and problem-resolution skills.
• Client-oriented mindset with the willingness to travel domestically and potentially internationally.

• Ability to prioritize and manage tasks effectively to ensure project goals are met.
• Proactively addresses challenges to drive project completion.

• Adapts technical communication for diverse audiences.
• Cultivates interdepartmental relationships to promote teamwork.

• Exemplifies integrity and dedication to ongoing improvement.
• Actively seeks professional growth opportunities and supports the development of team members.