Validation Manager

Validation Manager

Penn Life Sciences is seeking an experienced Validation Manager to join our team in Langhorne, PA.

The Validation Manager is responsible for leading and executing the site's validation strategy in support of sterile injectable manufacturing operations. Reporting to the Vice President of Technical Services, this role oversees validation programs for facilities, utilities, equipment, processes, cleaning, and computerized systems to ensure sustained compliance with cGMP and regulatory requirements. The ideal candidate will demonstrate strong technical leadership, expertise in risk-based commissioning and qualification, and hands-on experience supporting sterile manufacturing readiness within a regulated pharmaceutical environment.

This position's responsibilities will include, but not be limited to the following:

• Lead and manage site-wide validation activities for facilities, utilities, equipment, processes, cleaning, and computerized systems to maintain a state of validation readiness.
• Establish, maintain, and execute Validation Master Plans (VMPs) aligned with site objectives, regulatory expectations, and production timelines.
• Author, review, and approve validation documentation including URS, FRS, DQ, IQ, OQ, PQ protocols and reports, SOPs, change controls, deviations, and CAPAs.
• Implement and sustain risk-based commissioning and qualification (C&Q) strategies, leveraging commissioning data to streamline qualification activities.
• Oversee validation of critical sterile manufacturing systems including autoclaves, depyrogenation tunnels, lyophilizers, terminal sterilization systems, and cleanroom environments.
• Provide technical leadership, mentoring, and performance oversight for validation personnel to ensure consistent execution and documentation quality.
• Support regulatory inspections, internal audits, and cross-functional initiatives by representing the Validation function and ensuring compliance with FDA, EU Annex 15, and ICH requirements.

We are looking for applicants with:

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline required; Master's degree preferred.
• Minimum 7+ years of progressive validation experience in a cGMP-regulated pharmaceutical or biopharmaceutical manufacturing environment with a focus on sterile operations.
• At least 2+ years of experience leading validation personnel, projects, or major qualification programs.
• Demonstrated expertise in commissioning and qualification (C&Q), equipment and process validation, and validation lifecycle documentation.
• Strong working knowledge of 21 CFR Parts 210, 211, and 11, EU Annex 15, and applicable ICH guidance.

What we offer:

• 401(k) with company match
• Health, vision, and dental Insurance
• Childcare expense reimbursement
• Tuition reimbursement
• Annual bonus eligibility
• Annual merit increases
• Paid Time Off and Flexible Holidays

Penn Life Sciences is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, sexual orientation or any other protected status.

We encourage you to apply if you feel that you are a match! We look forward to hearing from you.