Penn Life Sciences is seeking a Validation Engineer I to join our team in Langhorne, PA.
The Validation Engineer I will support commissioning, qualification, and validation activities for GMP equipment, utilities, and manufacturing processes within a sterile pharmaceutical environment. This role assists in executing validation protocols, collecting and documenting data, and authoring validation documentation including IQ, OQ, and PQ protocols and reports. The ideal candidate will demonstrate a foundational understanding of cGMP principles, strong attention to detail, and a willingness to develop technical expertise within a regulated manufacturing environment.
This position's responsibilities will include, but not be limited to the following:
- Execute equipment qualification activities including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) testing in accordance with approved protocols.
- Support process validation activities through protocol execution, data collection, and documentation of results.
- Perform cleaning validation testing and sample collection to verify residue removal and contamination control.
- Author and maintain validation documentation including protocols, test scripts, and summary reports under the guidance of senior validation personnel.
- Collect, review, and document validation data to ensure accuracy, traceability, and compliance with data integrity requirements.
- Support validation activities related to new equipment installations, system modifications, and routine requalification efforts.
- Assist in troubleshooting and documenting atypical results encountered during validation execution.
We are looking for applicants with:
- Bachelor's degree in Engineering, Life Sciences, or a related technical discipline required.
- 0-2 years of experience in validation, engineering, quality, or technical operations within a GMP-regulated pharmaceutical or biopharmaceutical environment.
- Exposure to validation lifecycle concepts (IQ, OQ, PQ) preferred.
- Experience in sterile manufacturing, aseptic processing, utilities, or regulated production environments is a plus but not required.
- Foundational understanding of cGMP principles and data integrity expectations.
- Strong technical writing skills with emphasis on accuracy and documentation clarity.
- Proficiency with Microsoft Office applications including Word and Excel.
- Strong organizational skills and ability to manage multiple tasks and deadlines.
- Effective written and verbal communication skills with the ability to collaborate across departments.
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.