About Careertakes

👉 Important disclosure: Careertakes is a third-party recruiting platform supporting this hiring process. If selected, you will be employed directly by our client, a pharmaceutical manufacturing / life sciences company.

Applicants for this role may also receive access to additional matched opportunities through the Careertakes platform.

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Overview

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 is an entry- to early-career role suitable for recent engineering or life-sciences graduates. The position works cross-functionally with Manufacturing, Quality Assurance, Engineering, Facilities, Microbiology, and Quality Control to help maintain regulatory compliance and a validated state.

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What You’ll Do

• Execute assigned qualification, validation, requalification, and verification protocol activities per approved protocols and procedures.
• Prepare validation areas, test materials, instruments, data loggers, sample containers, forms, and supporting documentation for scheduled execution.
• Verify equipment identification, calibration status, instrument readiness, and availability of required materials before testing.
• Collect, record, organize, reconcile, and submit validation observations, test results, instrument readings, data sheets, calibration records, and supporting evidence following Good Documentation Practices.
• Support validation activities for facilities, utilities, manufacturing and laboratory equipment, cleaning/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.

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Qualifications

• Experience

  • 0–2 years in validation, commissioning, engineering, manufacturing, quality assurance, technical operations, laboratory operations, or another regulated pharmaceutical/biotech/medical-device/life-sciences environment.
  • Internship, cooperative education, academic laboratory, or technical-training experience involving equipment, testing, documentation, manufacturing, engineering, or quality activities is considered.
  • Prior exposure to sterile manufacturing, cleanroom operations, aseptic processing, utilities, or equipment qualification is a plus but not required.

• Education

  • Associate degree, technical diploma, or 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.

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Skills & Knowledge

• Basic understanding of cGMP requirements, Good Documentation Practices, data integrity, and controlled-document procedures.
• Familiarity with validation lifecycle concepts (commissioning, IQ/OQ/PQ, requalification), change control, deviations, and CAPA.
• Ability to follow approved protocols, procedures, test instructions, and acceptance criteria while accurately recording results.
• Strong attention to detail, organization, and ability to manage multiple assignments with accurate records.
• Proficiency with Microsoft Word, Excel, and Outlook; experience with electronic document-management systems preferred.
• Good communication skills and willingness to escalate issues when appropriate.

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Compensation & Benefits

• Estimated base pay: $101,226 per year (estimated)
• Annual performance bonus eligibility
• Annual merit-based pay increases
• 401(k) automatic enrollment at 3% pre-tax with 50% company match on the first 6% contributed
• Paid time off and 10 paid company holidays
• Medical, dental, vision, and life insurance coverage
• Professional development reimbursement and career growth opportunities
• Tuition reimbursement for children and childcare expense reimbursement

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Schedule & Location

• Full-time, on-site (Monday–Friday, 8:00 AM–5:00 PM)
• Location: Langhorne, PA (on-site at the client’s sterile manufacturing facility)

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Equal Opportunity & Hiring Transparency

Careertakes and our client are Equal Opportunity Employers committed to building a diverse and inclusive workforce. We prohibit discrimination or harassment of any kind. To support a fair and efficient hiring process, AI tools may be used to assist with application review or resume screening. These tools do not replace human decision-making. Final hiring decisions are made by people.

If you have questions about how your data is used, please contact us directly.