New · posted Oct 15
Prime Medicine · Biotechnology
Senior Quality Engineering Specialist
- Cambridge, MA
- On-site
- Full-time
- Senior & Principal
Open until filled
The role
The Senior Quality Engineering Specialist provides hands-on operational support for Prime Medicine’s GxP software, equipment, calibration, preventive maintenance, and vendor oversight activities. Working with Quality, Laboratory Operations, IT/Informatics, system and equipment owners, and external vendors, the Specialist executes qualification activities, maintains accurate records, coordinates scheduled work, and helps keep systems and equipment compliant and inspection-ready.
The role also conducts risk-based assessments of software vendors in accordance with current FDA guidance, as well as assessments of equipment and material suppliers and service providers, to ensure the quality and reliability of externally supplied inputs.
What you need
- Bachelor’s degree in a scientific, engineering, technical, or quality-related field, or equivalent relevant experience.
- At least four years of experience in a regulated life-sciences environment, including experience in equipment qualification, software assurance/CSV, calibration or maintenance oversight, supplier quality, or a related quality function.
- Working knowledge of GxP documentation, data integrity, computerized systems, equipment qualification, calibration, and preventive maintenance requirements.
- Experience drafting, executing, or reviewing qualification protocols, test scripts, assessments, or other controlled quality records.
- Experience using a computerized maintenance management, calibration management, or equipment tracking system.
- Strong technical writing, organization, and cross-functional coordination skills.
- Ability to manage multiple operational priorities, maintain accurate records, and escalate risks or delays promptly.
Preferred Experiencenice to have
- Experience in biotechnology, gene therapy, cell therapy, or another regulated life sciences environment.
- Familiarity with equipment lifecycle activities (URS, IQ/OQ/PQ, periodic review, calibration, maintenance) or software assurance/CSV practices.
- Experience supporting supplier qualification, vendor assessments, or laboratory instruments and CMMS records.
The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus) and an annual long-term incentive award (e.g., equity).
Prime Medicine offers a comprehensive Total Rewards package with robust health, financial, and wellness benefits—including medical, dental, vision, life insurance, a 401(k) match, and equity programs—along with generous paid time off, wellness days, and company-wide recharge breaks.
Our commitment to employee well-being reflects our belief that when we care for our people, we strengthen our ability to put patients first and make meaningful impact together.
U.S. Pay Range
$111,000—$123,000 USD
What you'll do
Software Assurance and Vendor Assessments
- Draft, execute, and review software assurance test scripts using approved requirements, specifications, risk assessments, and intended-use documentation.
- Support quality oversight of GxP computerized systems, including AI-enabled software tools, in accordance with company procedures and applicable regulatory expectations.
- Conduct and document risk-based assessments of software, equipment, material, and service providers.
- Collect and review vendor questionnaires, certifications, audit materials, quality agreements, and other supporting evidence.
- Work with IT/Informatics, system owners, Quality colleagues, and vendors to resolve documentation or performance gaps and complete assigned actions.
Equipment Qualification and Maintenance
- Draft, execute, and review equipment qualification protocols, including IQ/OQ/PQ activities.
- Review executed protocols, reports, raw data, test results, certificates, and supporting records for completeness, accuracy, and consistency.
- Support the documentation and investigation of equipment qualification discrepancies.
- Maintain equipment, calibration, and preventive maintenance records in the computerized maintenance management system.
- Review and electronically maintain calibration certificates, maintenance records, and service reports, ensuring that documentation is complete and properly linked to the applicable equipment.
- Oversee scheduled calibration, maintenance, and service activities with equipment owners and external providers, escalating delays and compliance risks promptly.
Supplier Quality and Quality Systems Support
- Conduct supplier audits and remote assessments under the direction of Supplier Quality leadership.
- Prepare assessment plans, document requests, questionnaires, reports, and follow-up actions.
- Track vendor corrective actions and other assigned quality actions through closure.
- Support change controls, deviations, CAPAs, and other quality records involving software, equipment, calibration, maintenance, or vendors.
- Maintain trackers, dashboards, and status reports for qualification activities, calibration and maintenance schedules, vendor assessments, and open actions.
- Identify recurring issues, documentation gaps, overdue activities, and opportunities for practical process improvement.
- Participate in audits, regulatory inspections, and inspection-readiness activities as needed.
Pay and benefits
$111,000 – $123,000 a year
Employer providedMedical, dental, vision, life insurance
401(k) match
Equity programs
Annual bonus eligibility
Generous paid time off
Wellness days and company-wide recharge breaks
Where you'll work
Cambridge, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Cambridge, MAFrom the posting
About Prime Medicine
Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types.
Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around our core areas of focus: hematology, immunology & oncology, liver and lung. Across each core area, Prime Medicine is focused initially on a set of high value programs, each targeting a disease with well-understood biology and a clearly defined clinical development and regulatory path, and each expected to provide the foundation for expansion into additional opportunities. For more information, please visit www.primemedicine.com.
Department: Quality Assurance
Reports to: VP, Quality Assurance
Location: Cambridge, MA
Equal opportunity, accessibility and legal noticesPrime Medicine's statements, word for word
Prime Medicine is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, disability, veteran status, or any other classification protected by law.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 5% below the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in Massachusetts25 roles publishing pay
Senior & Principal roles in the US284 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $111,000 | — | $123,000 |
| Massachusetts (middle half) | $108,500 | $125,000 | $133,000 |
| All US (middle half) | $103,375 | $122,750 | $137,500 |
This role: Prime Medicine's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Prime Medicine's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 38 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Documentation and SOPs18
- Data and digital systems12
- Validation and qualification10
- Quality systems and risk8
- GMP and compliance7
- Lab testing and methods5
- Investigations and CAPA2
- Collaboration and leadership2
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Prime Medicine on Regulatory Jobs
- 3
- Open roles
- 3
- Distinct roles
- 1
- Locations
By discipline
- Regulatory2 67%
- Quality1 33%
By level
- VP & Executive1 33%
- Manager1 33%
- Senior & Principal1 33%
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Senior Quality Engineering Specialist at Prime Medicine
Open until filled. $111K–$123K a year, employer provided.