Validation Associate (Recent Engineering Grads welcome to apply)

Job Description

Job Description

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 Associate supports commissioning, qualification, validation, requalification, and documentation activities for GMP equipment, utilities, processes, controlled environments, and supporting systems within a sterile injectable manufacturing facility. This role performs defined protocol activities, prepares validation materials and equipment, collects technical data, and maintains complete and accurate documentation under the direction of experienced Validation personnel. The Validation Associate works cross-functionally with Manufacturing, Quality Assurance, Engineering, Facilities, Microbiology, and Quality Control to support regulatory compliance and maintenance of the validated state.

Key Responsibilities:

• Execute assigned qualification, validation, requalification, and verification protocol activities in accordance with approved protocols and procedures.

• Prepare validation areas, test materials, instruments, data loggers, sample containers, forms, and supporting documentation for scheduled execution activities.

• Verify equipment identification, calibration status, instrument readiness, and availability of required materials before performing assigned validation testing.

• Record, organize, reconcile, and submit validation observations, test results, instrument readings, data sheets, calibration records, and supporting evidence in accordance with Good Documentation Practices.

• Support validation activities involving facilities, utilities, manufacturing and laboratory equipment, cleaning processes, sterilization systems, controlled environments, and computerized systems, as assigned.

• Identify and promptly escalate protocol discrepancies, atypical results, equipment issues, missing documentation, test failures, and departures from approved procedures.

• Assist with validation documentation, investigations, change controls, deviations, CAPAs, equipment installation, commissioning, audit readiness, and maintenance of validation trackers and requalification schedules.

What We’re Looking For

Experience:

• 0–2 years of experience in validation, commissioning, engineering, manufacturing, quality assurance, technical operations, laboratory operations, or another regulated pharmaceutical, biotechnology, medical device, or life-sciences environment.

• Internship, cooperative education, academic laboratory, technical-training, or entry-level industry experience involving equipment, testing, documentation, manufacturing, engineering, or quality activities may be considered.

• Experience following written procedures, recording technical data, maintaining controlled documentation, or working within a regulated environment preferred.

• Prior exposure to sterile manufacturing, cleanroom operations, aseptic processing, utilities, equipment qualification, or pharmaceutical production preferred but not required.

Education:

• Associate degree, technical diploma, or an equivalent combination of education, training, and relevant experience required.

• Bachelor’s degree in Engineering, Life Sciences, Chemistry, Biology, Pharmaceutical Sciences, Manufacturing Technology, or a related technical discipline strongly preferred.

Skills & Knowledge:

• Basic understanding of cGMP requirements, Good Documentation Practices, data integrity, and controlled-document procedures.

• Basic knowledge of validation lifecycle concepts, including commissioning, IQ, OQ, PQ, requalification, change control, deviations, and CAPA.

• Ability to follow approved protocols, procedures, test instructions, and established acceptance criteria while accurately recording technical results.

• Ability to recognize and promptly escalate discrepancies, abnormal results, missing documentation, and equipment issues.

• Strong attention to detail, organizational skills, and ability to manage multiple assignments and maintain accurate records.

• Proficiency with Microsoft Office applications, including Word, Excel, and Outlook; experience with electronic document-management systems preferred.

What We Offer

• Competitive annual base salary 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 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 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.