The Opportunity:Avantor is looking for a Quality Validation Engineer to join our Quality team and make an impact through validation governance, regulatory compliance, ownership of validated system lifecycles, and independent review and approval of validation deliverables.
This role is hybrid out of our Devens, MA site.
What we're looking for- Education: Bachelor's degree in Engineering, Computer Science/Information Systems, Life Sciences, or related technical discipline; or a combination of education and experience that would provide the required knowledge, skills, and abilities
- Experience: 3-7+ years of validation experience in a regulated manufacturing environment with demonstrated CSV experience
- Demonstrated knowledge of risk-based validation and quality systems (change control, deviation/CAPA, document control, training)
- Working knowledge of applicable regulations/standards (e.g., ISO 9001, cGMP/21 CFR 210/211; EU GMP Annex 11, GAMP 5)
- Preferred Qualifications:
- Experience supporting electronic batch record (EBR) systems
- Relevant Engineering and/or Quality certifications
- Experience with ERP systems
- Bioprocessing, single-use, or medical device industry background
How you will thrive and create an impactThe Engineer leads and supports validation activities to ensure compliance, product quality, data integrity, and maintenance of a sustained validated state. The role has primary responsibility for Computer System Validation (CSV) of Quality and GxP computerized systems and provides Quality validation governance for controlled environments (e.g., ISO cleanrooms and supporting utilities). The role partners cross-functionally to support new product introductions (NPI), facility expansions, and process or system changes by defining validation strategy, coordinating execution with stakeholders, and independently reviewing/approving validation evidence.
- Own and execute the CSV lifecycle for Quality and GxP computerized systems (e.g., eQMS, EDMS/training, LIMS, ERP, EM systems, quality-related interfaces), including validation planning, risk assessment, User Requirements specifications, traceability, protocol oversight, reporting, release to use, periodic review, and retirement.
- Ensure validated state is maintained through change control impact assessments and deviation assessments, providing validation support and oversight for related system controls and testing activities in partnership with IT and system owners.
- Support Quality validation governance for cleanrooms and controlled environments, including development/maintenance of qualification plans and protocols, review of test data/results (e.g., ISO classification, airflow/pressure relationships, recovery, temperature/humidity mapping, and environmental mapping where applicable), and definition of requalification triggers tied to change control, maintenance, and risk.
- Support NPI, tech transfer, automation implementation, and major change projects by defining risk-based validation strategy and aligning validation deliverables to project stage-gates. Coordinating cross-functional execution.
- Provide independent Quality oversight and approval for production equipment qualification and process validation activities led by Operations/Engineering.
- Serve as site Validation/CSV subject matter expert for internal/external audits and inspections and support inspection readiness, gap assessments, and responses to validation/CSV observations.
- Track validation commitments, schedules, and metrics and communicate status, risks, and resource needs to Quality leadership and project teams.
KNOWLEDGE SKILLS AND ABILITIES- Proven ability to lead validation efforts and influence cross-functional teams, even without direct reports.
- Ability to author clear, audit-ready validation documentation including plans, risk assessments, URS/specifications, traceability matrices, protocols, and reports.
- Strong understanding of CSV concepts, SDLC, IT control areas (access control, backup/restore, patching, cybersecurity, disaster recovery) and how they support data integrity and validated state.
- Understanding of cleanroom concepts (airflow/pressure cascades, particulate control, recovery, HVAC performance, environmental monitoring interfaces) and the linkage to product and quality risk.
- Project management skills: planning, scheduling, stakeholder management, risk communication, and delivering to timelines with minimal supervision.
- Strong analytical/problem-solving skills and the ability to make sound, risk-based decisions and impact assessments.
- Excellent communication and influencing skills across Quality, Operations, Engineering/Facilities, IT, and suppliers/vendors.
- Ability to work effectively in a matrix environment and to coach/train others on validation expectations.
ENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT- Typically works in an office environment with adequate lighting and ventilation, and a normal range of temperature and noise level.
- The position involves a steady workload, balancing multiple priorities and adhering to frequent deadlines in a fast-paced environment.
- Some physical effort is required. Work may require walking, standing, bending, reaching, lifting, or carrying objects that typically weigh less than 25 lbs.
- Some travel may be required.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, skills, efforts or working conditions associated with a job.
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