About this role
Work Schedule
First Shift (Days)
Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Key Responsibilities
- Serve as the primary Facilities Engineering documentation interface between Facilities, Project Management, Validation, Quality, Maintenance, and other site stakeholders.
- Maintain and manage GMP As-Built drawings and Non-GMP Master Drawings to ensure engineering documentation accurately reflects current facility conditions.
- Develop and maintain procedures, standards, and periodic review schedules for engineering drawings and associated documentation.
- Maintain the master inventory of GMP and Non-GMP engineering drawings, including electronic and applicable hard-copy records, utilizing the Adept Documentation System.
- Coordinate CAD activities and drawing revisions using Adept and AutoCAD, ensuring drawings are accurate, properly reviewed, controlled, and compliant with site requirements.
- Perform field walkdowns and work with Facilities Engineers, contractors, and project teams to verify that engineering drawings accurately reflect installed conditions.
- Provide oversight and guidance to project contractors to ensure drawings, turnover packages, and other engineering documentation meet site standards before project closeout.
- Support the Facilities organization with CMMS activities, including work requests, work orders, equipment records, preventive maintenance documentation, and other system administration activities. Experience with Blue Mountain/BMRAM is preferred.
- Support new equipment onboarding and turnover by coordinating required drawings, documentation, equipment information, maintenance requirements, and CMMS records.
- Support deviations, CAPAs, Change Controls, and risk assessments by coordinating documentation and assigned implementation activities.
- Manage applicable EDMS workflows for document routing, review, approval, revision, and archival.
- Support internal, client, and regulatory cGMP inspections by retrieving requested engineering and maintenance documentation and maintaining records in an audit-ready state.
- Assist with project documentation, contractor coordination, maintenance planning, and other Facilities Engineering activities as required.
- Identify opportunities to improve and standardize engineering documentation, CMMS, drawing control, and Facilities administrative processes.
- Provide backup support for critical Facilities administrative functions to ensure continuity during absences or staffing changes.
- Perform additional responsibilities as assigned by Facilities & Engineering leadership.
Minimum Qualificatio ns
- Bachelor’s/ associate's degree in engineering, Engineering Technology, Facilities Management, Construction Management, CAD/Drafting, or a related technical discipline; equivalent combination of education and relevant experience may be considered.
- 3+ years of experience in Facilities, Engineering documentation, CAD, document control, maintenance systems, or a related technical function.
- Experience working with engineering drawings and technical documentation.
- Experience with electronic document management systems (EDMS), controlled documentation, or engineering drawing management systems.
- Working knowledge of cGMP documentation practices and Quality systems.
- Experience supporting work orders, maintenance records, equipment documentation, or CMMS activities.
- Strong organizational skills and attention to detail, with the ability to manage multiple priorities and documentation deadlines.
- Strong written and verbal communication skills with the ability to work effectively across multiple departments.
- Proficiency with Microsoft Office applications, including Excel, Word, PowerPoint, Outlook, and Teams.
- Ability to perform facility walkdowns and verify documentation against actual field conditions.
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Preferred Qualifications
- Experience within pharmaceutical, biotechnology, life sciences, or another GMP-regulated manufacturing environment.
- Proficiency with AutoCAD and engineering drawing management.
- Experience with the Adept Document Management/CAD system.
- Experience with Blue Mountain Regulatory Asset Manager (BMRAM) or another CMMS.
- Knowledge of deviation, CAPA, Change Control, and equipment turnover processes.
- Experience supporting client, Quality, or regulatory inspections.
- Experience reviewing contractor drawing packages, redlines, as-builts, and project turnover documentation.
- Demonstrated ability to improve processes, establish documentation standards, and develop sustainable workflows.
- Previous experience providing technical leadership, coordinating work across teams, or mentoring other personnel.
Compensation and Benefits
The salary range estimated for this position based in Massachusetts is $83,300.00–$125,000.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
- A choice of national medical and dental plans, and a national vision plan, including health incentive programs
- Employee assistance and family support programs, including commuter benefits and tuition reimbursement
- At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
- Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
- Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards