Facilities Engineer

Trinity Consultants - Advent Engineering; Boston (MA); On-site; USD 100,000 - 160,000; Full time

Job summary

Trinity Consultants - Advent Engineering seeks experienced Facilities Engineers to support capital projects, modifications, equipment installations, commissioning activities, and lifecycle documentation within GMP-regulated pharmaceutical and biotechnology environments.

The role covers cleanrooms, laboratories, utilities, warehouses, and facility systems, collaborating with Engineering, Validation, Quality, Facilities, and Operations teams to ensure compliance and operational readiness.

Qualifications

• Bachelor’s degree in Engineering required, with discipline in Chemical, Mechanical, Electrical or related field.
• Minimum of 4+ years of experience in pharmaceutical, biotechnology, or other regulated manufacturing environments.
• Experience supporting site engineering, facilities engineering, process engineering, CQV, or validation activities in GMP environments.
• Experience with manufacturing equipment, clean utilities, facility systems, startup/qualification activities.

Responsibilities

• Review engineering design packages and vendor submittals for compliance with regulatory requirements.
• Develop, review, and update technical specifications for equipment and facility systems.
• Provide engineering oversight during design, fabrication, installation, startup, and commissioning activities.
• Coordinate activities with vendors, contractors, architects, engineers, and internal stakeholders.
• Support schedule reviews, risk assessments, and mitigation planning activities.
• Author, execute, review, and manage change controls in accordance with GMP and quality requirements.
• Review and update engineering drawings, P&IDs, SOPs, technical documentation, and as-built drawings.
• Support commissioning and qualification activities including FAT, SAT, IQ, OQ, and related protocols.
• Partner with Validation and Quality teams to ensure systems meet compliance and operational readiness requirements.
• Support deviation investigations, CAPAs, inspection readiness activities, and continuous improvement initiatives.

Skills

Commissioning & validation

GMP facilities knowledge

Engineering drawings & P&IDs

Cross-functional collaboration

Regulatory knowledge (FDA/EU)

Cleanroom familiarity

Systems: SCADA/EMS/BMS/CMMS

Education

Bachelor’s degree in Engineering

4+ years experience in regulated manufacturing

Tools

CMMS

BMS

EMS

SCADA

Job description

We are seeking experienced Facilities Engineers to support capital projects, facility modifications, equipment installations, commissioning activities, lifecycle documentation, and engineering deliverables within GMP-regulated pharmaceutical and biotechnology environments. This role will support manufacturing cleanrooms, laboratories, utilities, warehouses, and facility systems while collaborating cross-functionally with Engineering, Validation, Quality, Facilities, and Operations teams.

The ideal candidate will have strong experience in commissioning, qualification, validation, engineering documentation, and GMP facility support within regulated manufacturing environments.

Duties and Responsibilities

• Review engineering design packages and vendor submittals for compliance with operational, maintenance, and regulatory requirements.
• Develop, review, and update technical specifications for equipment and facility systems.
• Provide engineering oversight during design, fabrication, installation, startup, and commissioning activities.
• Coordinate activities with vendors, contractors, architects, engineers, and internal stakeholders.
• Support schedule reviews, risk assessments, and mitigation planning activities.
• Author, execute, review, and manage change controls in accordance with GMP and quality requirements.
• Review and update engineering drawings, P&IDs, SOPs, technical documentation, and as-built drawings.
• Support commissioning and qualification activities including FAT, SAT, IQ, OQ, and related protocols.
• Partner with Validation and Quality teams to ensure systems meet compliance and operational readiness requirements.
• Support deviation investigations, CAPAs, inspection readiness activities, and continuous improvement initiatives.
• Troubleshoot manufacturing, utility, and facility systems to support ongoing operations.
• Support startup, shutdown, impairment, and transition activities during project execution.
• Participate in operational, project, and cross-functional coordination meetings.
• Provide timely project updates, documentation, and status reporting.

Required Skills / Abilities

• Strong knowledge of GMP-regulated pharmaceutical or biotechnology manufacturing environments.
• Experience with commissioning, qualification, and validation of manufacturing equipment, clean utilities, HVAC systems, and cleanrooms.
• Ability to read and interpret engineering drawings, P&IDs, specifications, equipment manuals, and vendor documentation.
• Knowledge of FDA and EU regulatory requirements including 21 CFR Part 11, Annex 1, GMP, GEP, ISO, GAMP, USP, ASME BPE, ISA, and ANSI standards.
• Experience creating and managing lifecycle documentation including:
• Impact Assessments
• User Requirements Specifications (URS)
• Functional Specifications
• FAT/SAT protocols
• IQ/OQ protocols
• CQV documentation
• Experience managing change controls, deviations, and CAPAs within GMP environments.
• Familiarity with cleanroom classifications (ISO 5/7/8 and Grade A/B/C/D environments).
• Experience with CMMS, BMS, EMS, and SCADA systems preferred.
• Strong technical writing, communication, and cross-functional collaboration skills.
• Ability to gown and work within cleanroom and aseptic manufacturing environments.

Education and Experience

• Bachelor’s degree in Engineering (Chemical, Mechanical, Electrical, or related discipline) required.
• Minimum of 4+ years of experience within pharmaceutical, biotechnology, or other regulated manufacturing environments.
• Experience supporting site engineering, facilities engineering, process engineering, CQV, or validation activities in GMP environments required.
• Experience with manufacturing equipment, clean utilities, facility systems, and startup/qualification activities strongly preferred.