Validation Associate (Recent Engineering Grads welcome to apply)

Job Description

Job Description

Validation Engineer I

About Penn Life Sciences

Penn Life Sciences (PLS) is a rapidly growing pharmaceutical manufacturer dedicated to producing high-quality sterile generic drug products. Headquartered in Langhorne, Pennsylvania, PLS is developing a modern, U.S.-based sterile manufacturing facility designed to meet the highest FDA and global cGMP standards. Our mission is to strengthen domestic pharmaceutical supply, enhance patient access to affordable, life-saving medications, and uphold the values of integrity, innovation, and scientific excellence in everything we do.

What You’ll Do

The Validation Engineer I supports 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 test data, and authoring validation documentation such as IQ, OQ, and PQ protocols and reports under the guidance of senior validation staff. The Validation Engineer I helps ensure manufacturing systems remain in a validated state while supporting regulatory compliance, production readiness, and adherence to cGMP standards.

Key Responsibilities

• 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 validation results.
• Execute cleaning validation testing and collect samples to verify effective 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 efforts related to new equipment installations, system modifications, and routine requalification activities.
• Assist in troubleshooting and documenting atypical results encountered during validation execution.
• Initiate and support change controls, deviations, and CAPA records associated with validation activities within the site Quality Management System.
• Ensure compliance with Penn Life Sciences SOPs, safety requirements, and applicable cGMP regulations.
• Support validation readiness activities for internal audits and regulatory inspections as assigned.

What We’re Looking For

Experience

• 0–2 years of experience in validation, engineering, quality, or technical operations within a GMP-regulated pharmaceutical or biopharmaceutical manufacturing environment.
• Exposure to validation lifecycle concepts including IQ, OQ, and PQ preferred.
• Experience in sterile manufacturing, aseptic processing, utilities, or regulated production environments is a plus but not required.

Education

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline required.

Skills & Knowledge

• Foundational understanding of cGMP principles and validation lifecycle concepts.
• Ability to follow approved protocols and procedures with strong attention to detail.
• Strong technical writing skills with emphasis on documentation accuracy and clarity.
• Proficiency with Microsoft Office applications including Word and Excel.
• Strong organizational skills with the ability to manage multiple tasks and deadlines.
• Effective written and verbal communication skills.
• Willingness to learn, accept feedback, and develop technical competency within a regulated pharmaceutical environment.

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)

Penn Life Sciences (PLS) is a rapidly growing pharmaceutical manufacturer dedicated to producing high-quality sterile generic drug products. Headquartered in Langhorne, Pennsylvania, PLS is developing a modern, U.S.-based sterile manufacturing facility designed to meet the highest FDA and global cGMP standards. Our mission is to strengthen domestic pharmaceutical supply, enhance patient access to affordable, life-saving medications, and uphold the values of integrity, innovation, and scientific excellence in everything we do.

Company Description

Penn Life Sciences (PLS) is a rapidly growing pharmaceutical manufacturer dedicated to producing high-quality sterile generic drug products. Headquartered in Langhorne, Pennsylvania, PLS is developing a modern, U.S.-based sterile manufacturing facility designed to meet the highest FDA and global cGMP standards. Our mission is to strengthen domestic pharmaceutical supply, enhance patient access to affordable, life-saving medications, and uphold the values of integrity, innovation, and scientific excellence in everything we do.