Validation Engineer II

Responsibilities:

• Manage and execute commissioning, qualification, and validation (CQV) lifecycle activities supporting internal GMP drug substance manufacturing.
• Create and maintain site Validation Master Plans, CQV protocols/procedures, and templates using a science and risk-based approach.
• Lead cross-functional teams through system impact evaluations and system risk assessments; perform gap assessments and remediate new risks when new equipment/products are introduced.
• Train and mentor junior Validation Engineers and internal Subject Matter Experts in qualification best practices.
• Assist with preparation and maintenance of User Requirements Specifications.
• Prepare and execute installation/operation/performance qualification protocols for pharmaceutical manufacturing equipment, utilities, and automation systems; manage study completion and meet project timelines.
• Prepare and review CQV reports.
• Independently review proposed changes for impact to system qualification and validation; complete targeted requalification activities.
• Establish and maintain internal recordkeeping for periodic reviews; complete periodic reviews per assigned schedules.
• Maintain qualification documentation in a state of GMP compliance; support audits.
• Author deviations and corrective action plans; assign and track action items and drive completion to schedule.
• Identify and manage closure of qualification lifecycle document gaps.
• Identify and propose process improvement ideas and contribute to implementation.
• Collaborate with cross-functional teams to meet deliverables and timelines.

• Minimum 12 years of validation engineering experience, preferably in pharmaceutical drug substance manufacturing.
• Ability to read and understand engineering drawings (e.g., P&IDs, electrical drawings, functional specifications).
• Bachelor’s degree in Engineering or related scientific field.
• Thorough understanding of cGMP and FDA requirements.
• Strong communication and documentation skills.
• Experience with equipment qualification per ISPE and ASTM guidelines.
• Proficient with Microsoft Office Suite.

• Experience qualifying equipment integrated with process control systems; shared equipment in multi-product facilities.
• Experience implementing ISPE Baseline Guide 5, Volume 2.
• Familiarity with Blue Mountain Regulatory Asset Manager software.

Wisconsin pay range: $120,000 USD - $145,000 USD