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 company.

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

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Key Responsibilities

• Perform validation, calibration, and qualification activities for pharmaceutical manufacturing and sterile‑processing equipment (IQ/OQ/PQ).
• Support development and execution of Master Validation Plans, SOPs, and validation protocols.
• Assist with process performance qualification (PPQ), aseptic processing, cleaning & sterilization validation.
• Execute equipment qualification (Installation, Operational, Performance) and routine equipment performance monitoring.
• Calibrate lab and production instruments (e.g., light meters, shakers, scales) and maintain calibration records.
• Support validation for CIP skids, isolators, parts washers, autoclaves, and related cleaning/sterilization systems.
• Complete validation and qualification documentation accurately and on time.
• Collaborate with validation, engineering, quality, and manufacturing teams to resolve issues and implement improvements.
• Follow Good Manufacturing Practices (GMP) and 21 CFR Part 11 requirements in daily work.

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Qualifications

• Entry-level candidates or recent graduates with up to six months of relevant experience or academic exposure to validation, calibration, CSV, CQV, pharmaceutical manufacturing, or other regulated environments.
• Basic understanding of GMP and 21 CFR Part 11.
• Familiarity with IQ/OQ/PQ methodology and validation lifecycle documentation.
• Knowledge or coursework in Computerized System Validation (CSV) is strongly preferred.
• Bachelor’s degree preferred in Engineering, Life Sciences, Pharmaceutical Sciences, Biotechnology, or related discipline.
• Strong attention to detail and excellent documentation skills.
• Effective problem-solving, verbal/written communication, and teamwork skills.
• Must be able to work on-site at client facilities in both Waltham and Cambridge, Massachusetts.

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Why Apply?

• Hands-on experience with pharmaceutical validation and CQV processes.
• Exposure to critical sterile‑processing and manufacturing equipment.
• Build practical skills in GMP, CSV, IQ/OQ/PQ, calibration, and 21 CFR Part 11.
• Opportunity for permanent employment following the initial contract period — strong path for career growth.

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Location & Work Requirements

• On-site role. Local candidates must be available to work at client facilities in both Waltham and Cambridge, MA.
• Reasonable accommodations will be provided as required by law.

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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.