Validation Engineer
Penn Life Sciences is looking for a Validation Engineer to join our team in Langhorne, PA.
The Validation Engineer will support the development, execution, and maintenance of site commissioning, qualification, and validation programs for equipment, utilities, cleaning, processes, and assays in compliance with cGMP and regulatory requirements. This role is instrumental in ensuring the validated state of sterile manufacturing systems, supporting both new installations and ongoing production operations. The ideal candidate will possess a strong technical foundation in validation principles, excellent documentation skills, and a proactive, hands-on approach to problem-solving within a regulated environment.
This position’s responsibilities will include, but not be limited to the following:
- Write, execute, and coordinate commissioning, qualification, and validation protocols (IQ/OQ/PQ) in support of Penn Life Sciences’ validation master plan and regulatory expectations.
- Develop, execute, and maintain validation documentation including URS, IQ/OQ/PQ protocols, reports, SOPs, change controls, deviations, and CAPAs.
- Compile, analyze, and interpret validation data; prepare detailed reports summarizing study results, conclusions, and recommendations.
- Support troubleshooting and conduct impact assessments for deviations or atypical conditions identified during validation activities.
- Participate in investigations, implement corrective and preventive actions (CAPAs), and initiate change controls where validation is impacted.
- Review completed validation, maintenance, and calibration records for technical accuracy and compliance.
We are looking for applicants with:
- Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline.
- 0–4 years of validation experience in a GMP-regulated pharmaceutical or biopharmaceutical environment.
- Experience authoring, executing, and reviewing validation documentation including IQ/OQ/PQ protocols and reports.
- Excellent analytical and problem-solving skills with strong attention to detail and documentation accuracy.
- Effective written and verbal communication skills; collaborative team orientation.
- Proficiency with Microsoft Word, Excel, PowerPoint, and statistical tools such as Minitab or JMP.
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.
