Validation Engineer II

The Validation Engineer II is an independent technical contributor responsible for executing commissioning, qualification, and validation activities for GMP equipment, utilities, and processes within a sterile pharmaceutical manufacturing environment. This role authors and executes validation documentation, leads assigned validation projects, and supports maintenance of the validated state in accordance with cGMP and regulatory requirements. The Validation Engineer II collaborates closely with Engineering, Quality Assurance, and Manufacturing, to ensure systems are inspection-ready and aligned with operational needs.

Key Responsibilities

• Independently plan and execute commissioning, qualification, and validation activities for GMP equipment, utilities, and systems in accordance with approved protocols and procedures.
• Author, execute, and finalize IQ/OQ/PQ protocols and validation reports with clear acceptance criteria and compliant documentation practices.
• Analyze validation data, evaluate results against acceptance criteria, and document conclusions supporting qualification status.
• Lead validation efforts for new equipment installations, system modifications, and periodic requalification activities.
• Initiate, manage, and close validation-related change controls, deviations, and CAPAs in accordance with the site Quality Management System (QMS).
• Perform and document impact assessments and risk-based evaluations for atypical results and system changes.
• Provide technical input during troubleshooting of equipment or system issues encountered during validation execution.
• Support validation readiness activities and serve as a technical contributor during internal audits and regulatory inspections.
• Maintain compliance with Penn Life Sciences SOPs, data integrity standards, and applicable FDA and global cGMP regulations.

What We’re Looking For

Experience

• 3–5 years of progressive validation experience in a GMP-regulated pharmaceutical or biopharmaceutical manufacturing environment.
• Demonstrated experience independently authoring, executing, and finalizing IQ/OQ/PQ protocols and reports.
• Hands-on experience supporting equipment, utility, or process validation activities.
• Prior experience in sterile manufacturing, aseptic processing, or cleanroom environments strongly preferred.

Education

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline required.
• Advanced degree (MS) preferred but not required.

Skills & Knowledge

• Strong working knowledge of validation lifecycle principles, commissioning and qualification (C&Q), and cGMP requirements.
• Proficiency in technical writing with the ability to produce clear, compliant validation documentation.
• Solid understanding of FDA regulations and data integrity principles.
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint); familiarity with electronic QMS systems preferred.
• Strong analytical, organizational, and problem-solving skills.
• Effective verbal and written communication skills with the ability to collaborate cross-functionally.

What We Offer

• Competitive compensation with annual performance bonus eligibility
• Annual merit-based pay increases
• Automatic enrollment in a 401(k) at 3% pre-tax with 50% company match on the first 6% contributed
• Paid Time Off
• 10 paid company holidays
• Comprehensive medical, dental, vision, and life insurance coverage
• Professional development reimbursement
• Career growth opportunities
• Tuition reimbursement for children and childcare expense reimbursement

Schedule

• Full-time, on-site position (Monday–Friday, 8:00 AM – 5:00 PM)