Validation Engineer II
Arrowhead Pharmaceuticals
5 months ago
On-site
Verona, WI
Operations
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.
Requirements:
- 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
Preferred:
- 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
Benefits/Pay:
- Wisconsin pay range: $120,000 USD - $145,000 USD
Application instructions:
- All applicants must have authorization to work in the US for a company.
- 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.
Requirements:
- 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
Preferred:
- 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
Benefits/Pay:
- Wisconsin pay range: $120,000 USD - $145,000 USD
Application instructions:
- All applicants must have authorization to work in the US for a company.