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, Engineering (Biopharmaceutical Manufacturing).

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

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Role overview

Confidential Client is hiring a Commissioning Engineer (Associate - Level II) to support commissioning and qualification activities at a bioproduction facility in West Lebanon, NH. This is an onsite, full-time role focused on commissioning equipment, utilities and systems in accordance with science- and risk-based validation (SRV) and applicable regulatory requirements.

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What you’ll do

• Maintain a working knowledge of facilities, utilities, systems and equipment operations in a biopharmaceutical manufacturing environment.
• Author, review and execute commissioning and verification protocols (including SAT/FAT), analyze commissioning data and prepare final reports.
• Support specification development, supplier selection and commissioning/qualification/verification through project phases.
• Implement consistent best practices for commissioning protocols and execution.
• Ensure accuracy, traceability and regulatory compliance of commissioning and system records.
• Partner with Validation, Manufacturing, Facilities Engineering and Quality teams to align commissioning activities with SRV and regulatory expectations (FDA, EMA).
• Support Deviations (DVs) and Change Requests (CRs) related to commissioning scope.
• Provide technical input and act as a site subject-matter point of contact for commissioning topics.
• Assist with facility certification activities for new or upgraded pharmaceutical manufacturing and QC facilities.
• Support audits and inspections by providing commissioning data, rationale and documentation.
• Perform other related duties as assigned.

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Qualifications

• Education
  • Associate’s degree in life science or engineering (required).
  • Bachelor’s degree in life science or engineering (preferred).
• Experience
  • Associate’s degree + ~2 years related experience (required) OR Bachelor’s degree + ~1 year related experience (preferred).
  • Prior experience in pharmaceutical process, biotechnology or GMP environment is preferred but not required.
• Knowledge & skills
  • Familiarity with commissioning and validation concepts, change control and cGMP documentation practices.
  • Experience with data analysis and technical report writing.
  • Strong written and verbal communication skills.
  • Ability to work across cross-functional teams and to operate independently.
  • Willingness to learn root cause analysis techniques and SRV approaches on the job.

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Benefits & perks

• Competitive pay and annual performance bonus.
• Generous paid time off (example: 36 paid days including vacation, sick and company holidays).
• Medical, dental and vision insurance options.
• Retirement benefits (guaranteed company contribution and match options).
• Paid parental leave and other family support benefits.
• Access to site-specific employee programs and resources.

(The exact benefits package will be provided by the hiring organization during recruitment.)

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Work location & schedule

• Onsite at the bioproduction facility in West Lebanon, NH.
• Typical schedule: Monday–Friday, daytime hours.
• Local and international travel: up to ~10% as needed.

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Physical requirements

• Ability to climb, stoop, kneel, crouch, crawl, reach, stand and walk.
• Ability to push, pull, lift (up to ~33 lbs occasionally), finger, feel and grasp.
• Visual acuity for close work, reading and inspection.
• Ability to work in varied environmental conditions (noise, narrow aisles, temperature changes, occasional odors/fumes/dust).
• Repetitive hand/wrist activity may be required.

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Compliance & culture

• Perform all duties in a compliant and ethical manner consistent with applicable healthcare laws, regulations and industry codes.
• Support an inclusive recruitment process and equal opportunity for all applicants.
• Incorporate site and corporate principles in daily work and interactions.

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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.