Supporting manufacturing equipment, utilities, and facility systems in a GMP-regulated pharmaceutical environment is the core of this Site Engineer role. The position involves engineering design review, technical oversight, change control management, and commissioning and qualification support, working closely with cross-functional teams and external partners.
Responsibilities
Review engineering design packages and vendor submittals for compliance with company standards, applicable building codes, operational requirements, and maintenance expectations
Review, update, and develop technical specifications for equipment and facility systems
Provide engineering oversight throughout design, fabrication, installation, and startup; coordinate with architects and engineers (A&E firms), vendors, construction teams, and internal stakeholders; and participate in schedule reviews, technical risk assessments, and mitigation planning
Author, execute, review, and own change controls in accordance with company standard operating procedures (SOPs), Quality Assurance (QA) requirements, Engineering expectations, Facilities guidelines, and applicable GMP regulatory requirements
Review, modify, and approve engineering drawings, piping and instrumentation diagrams (P&IDs), submittals, SOPs, and technical literature; develop redlines, as-built documentation, and engineering updates
Support commissioning of manufacturing and facility systems, including execution and review of Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), Operational Qualification (OQ), and other commissioning and qualification protocols; collaborate with validation teams to ensure system readiness and alignment with Quality and Regulatory requirements
Support continuous improvement, deviation resolution, corrective and preventive actions (CAPA), and inspection readiness for regulatory audits
Perform on-floor equipment and system troubleshooting to restore operational capability and support continuous operations
Support impairment and startup activities during construction, shutdowns, and project execution, and assist with system transitions to maintain business continuity
Participate in operational and coordination meetings as requested and provide timely updates and service reporting
Provide engineering support for planned facility shutdowns
Requirements
Minimum of four years of relevant experience performing site, facilities, plant, or process engineering activities in an oral solid dose, biotechnology, or other regulated pharmaceutical manufacturing environment operating under GMP requirements
Bachelor’s degree in Chemical, Mechanical, Electrical Engineering, or another related engineering discipline
Experience in the design, implementation, startup, and qualification of GMP manufacturing, utility, and facility equipment
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Ability to read and interpret engineering drawings, specifications, equipment manuals, and vendor documentation
Strong communication, technical writing, and cross-functional collaboration skills, including preparation of GMP documentation subject to regulatory inspection
Understanding and application of engineering principles, theories, concepts, industry best practices, and applicable standards, including GMP, Good Engineering Practice (GEP), ISO, GAMP, USP, ASME BPE, ISA, and ANSI
Knowledge and experience applying FDA and EU regulatory requirements, including relevant 21 CFR requirements and Annex 1, to pharmaceutical manufacturing facilities and equipment
Experience creating and managing lifecycle documentation for manufacturing equipment, clean utilities, cleanrooms, and HVAC systems, including impact assessments, user requirements, functional specifications, software and hardware specifications, FAT, SAT, and commissioning, qualification, and validation (CQV) protocols
Experience owning GMP change controls for manufacturing equipment, clean utilities, cleanrooms, and HVAC systems
Knowledge of FDA and EU cleanroom classifications and operations, including ISO 8/7/5 and Grade D/C/B/A cleanroom environments
Experience using a Computerized Maintenance Management System (CMMS)
Experience with Building Management Systems (BMS), Environmental Monitoring Systems (EMS), and Supervisory Control and Data Acquisition (SCADA) systems
Ability to gown into cleanrooms and successfully complete the company gowning qualification requirements for entry into aseptic manufacturing spaces
Proven team collaboration experience and the ability to work cohesively with multiple cross functional groups
Benefits
Medical, dental, and vision insurance
Employee Assistance Program (EAP)
401K
Short-Term Disability (STD)
Long-Term Disability (LTD)
Accidental Death & Dismemberment (AD&D)
Life insurance
Paid parental leave
Reward & recognition program
Wellbeing benefits
Adoption assistance
Tuition reimbursement
Nine paid holidays
15 days PTO that accrue per year
About the Company
Arcadis is a leading company delivering sustainable design, engineering, and consultancy solutions for natural and built assets. It employs more than 36,000 people in over 70 countries, dedicated to improving quality of life.
