Validation Engineer II

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

The Validation Engineer II will independently execute equipment validation, process validation, and cleaning validation activities for GMP equipment, utilities, and manufacturing processes supporting sterile pharmaceutical operationsThis role ensures systems remain in a compliant validated state and supports production readiness, system changes, and regulatory inspection requirements. The ideal candidate will demonstrate strong technical judgment, hands-on validation experience, and the ability to author and execute validation documentation within a regulated cGMP environment.

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

• 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, assess 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.

We are looking for applicants with:

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline required; advanced degree preferred.
• Minimum 2–5 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.
• Strong working knowledge of validation lifecycle principles, commissioning and qualification (C&Q), and cGMP requirements.
• Excellent technical writing, analytical, and documentation skills with a high level of attention to detail.
• Effective written and verbal communication skills and the ability to collaborate cross-functionally

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.