Site Engineer

DPS Group Global; Boston (MA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical

Dental

Vision

EAP

401K

STD

LTD

AD&D

Life insurance

Paid parental leave

Reward & recognition program

Wellbeing benefits

Adoption assistance

Tuition reimbursement

Nine paid holidays

15 days PTO

Job summary

Arcadis is seeking a Facilities Project Engineer to support manufacturing equipment, utilities, and facility systems in a GMP-regulated pharmaceutical environment. You will review engineering design packages, oversee change controls, and participate in commissioning, qualification, and validation activities to ensure compliant, reliable operations.

The role requires at least four years of relevant experience in regulated pharma settings and a degree in Chemical/Mechanical/Electrical Engineering.

Qualifications

• Minimum of four years of relevant experience performing site, facilities, plant, or process engineering activities in a GMP-regulated pharmaceutical manufacturing environment.
• Bachelor’s degree in Chemical, Mechanical, Electrical Engineering, or another related engineering discipline.
• Experience in designing, implementing, starting up, and qualifying GMP manufacturing, utility, and facility equipment.
• Ability to read and interpret engineering drawings, specifications, manuals, and vendor documentation.
• Strong communication, technical writing, and cross-functional collaboration skills for GMP documentation.
• Familiarity with FDA and EU regulatory requirements (21 CFR, Annex 1) for pharmaceutical facilities and equipment.

Responsibilities

• Review design packages and vendor submittals for compliance with standards and regulatory requirements.
• Review and develop technical specifications for equipment and facility systems.
• Provide engineering oversight through design, fabrication, installation, and startup; coordinate with architects, vendors, and internal stakeholders.
• Own change controls per SOPs and regulatory requirements.
• Review drawings, P&IDs, submittals, SOPs, and literature; prepare as-built documentation and updates.
• Support commissioning and qualification activities (FAT, SAT, IQ, OQ) with validation teams.
• Support CAPA, deviation resolution, and inspection readiness for audits.
• Troubleshoot on-floor equipment and systems to restore operations.
• Assist with system transitions during construction, shutdowns, and startup to maintain business continuity.
• Participate in meetings and provide timely updates and service reporting.

Skills

Project management

GMP compliance

Change control

P&ID review

Cross-functional collaboration

Education

Bachelor's degree in Chemical/Mechanical/Electrical Engineering

Tools

CMMS

BMS

EMS

SCADA

CAD

Job description

Arcadis is the world's leading company delivering sustainable design, engineering, and consultancy solutions for natural and built assets.

We are more than 36,000 people, in over 70 countries, dedicated to improving quality of life. Everyone has an important role to play. With the power of many curious minds, together we can solve the world’s most complex challenges and deliver more impact together.

Arcadis is seeking a Facilities Project Engineer to support manufacturing equipment, utilities, and facility systems in a GMP-regulated pharmaceutical environment. This role provides engineering design review, technical oversight, change control management, and commissioning and qualification support. Working closely with cross-functional teams, vendors, and construction partners, the Site Engineer will troubleshoot equipment and system issues, maintain engineering documentation, and support project execution, startup, shutdown, and continuous improvement activities to help maintain compliant and reliable operations.

• 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.

Qualifications & Experience:

• 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.
• 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.

Why Arcadis?

We can only achieve our goals when everyone is empowered to be their best. We believe everyone's contribution matters. It’s why we are pioneering a skills-based approach, where you can harness your unique experience and expertise to carve your career path and maximize the impact we can make together.

You’ll do meaningful work, and no matter what role, you’ll be helping to deliver sustainable solutions for a more prosperous planet. Make your mark, on your career, your colleagues, your clients, your life and the world around you.

Together, we can create a lasting legacy.

Join Arcadis. Create a Legacy.

Our Commitment to Equality, Diversity, Inclusion & Belonging

We want you to be able to bring your best self to work every day which is why we take equality and inclusion seriously and hold ourselves to account for our actions. Our ambition is to be an employer of choice and provide a great place to work for all our people. We are an equal opportunity and affirmative action employer. Women, minorities, people with disabilities and veterans are strongly encouraged to apply. We are dedicated to a policy of non-discrimination in employment on any basis including race, creed, color, religion, national origin, sex, age, disability, marital status, sexual orientation, gender identity, citizenship status, disability, veteran status, or any other basis prohibited by law.

Arcadis offers benefits for full time and part time positions.

Benefits

• medical
• dental
• vision
• EAP
• 401K
• STD
• LTD
• AD&D
• life insurance
• paid parental leave
• reward & recognition program
• wellbeing benefits
• adoption assistance
• tuition reimbursement
• nine paid holidays
• 15 days PTO

We offer nine paid holidays and 15 days PTO that accrue per year. Salaries will vary and are based on several factors, such as experience, education, budget, internal equity, project and location.