Project Engineer

DPS Group Global; Harvard (MA); On-site; USD 110,000 - 170,000; Full time

Job summary

Arcadis is seeking a Technical Engineering professional to support the Viral Vector capital project at a Single-Use Facility. You will review FS, URS, FAT, SAT, P&IDs, and vendor documentation for automated bioprocess equipment such as ÄKTA chromatography and TFF skids.

Collaborate with engineering, automation, vendors, commissioning, and qualification teams to identify gaps and track open items, ensuring project timelines are met. Strong technical writing and GMP familiarity are required.

Qualifications

• Review FS/URS/FAT/SAT docs for completeness and traceability.
• Assess P&IDs, control narratives, and vendor specifications.
• Verify Maximo asset configurations and turnover packages.
• Support IQ/OQ protocols and validation activities.

Responsibilities

• Review FS for technical completeness and automation accuracy.
• Review URS, P&IDs, control narratives, and vendor docs.
• Review FAT protocols and records for acceptance traceability.
• Review SAT protocols and records, ensuring site conditions are tested.
• Review, redline, and approve P&IDs and instrument tagging.
• Apply DeltaV, UNICORN, and OPC UA knowledge to documentation.
• Review Maximo asset configurations before turnover.
• Support TCLs and TOPs generation and review.
• Provide SME-level review for IQ/OQ protocols and records.
• Identify discrepancies across engineering, automation, validation, and vendor docs.
• Maintain a document-review tracker with statuses and blockers.
• Provide weekly updates on review progress and volume.

Skills

Emerson DeltaV

Cytiva UNICORN

OPC UA integration

FS/URS/FAT/SAT document review

P&IDs review

Maximo CMMS

Single-use bioprocess equipment

IQ/OQ support

Technical writing

Discrepancy resolution

Education

Engineering degree (B.S./B.Eng.)

Tools

Maximo CMMS

P&ID review tools

Documentation management systems

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 Technical Engineering professional to support the Viral Vector capital project at a Single-Use Facility (SUF). The role will focus on the technical review, generation support, and approval of engineering, automation, asset-management, and validation documentation for automated and single-use bioprocess equipment. The individual will review Functional Specifications (FS), User Requirements Specifications (URS), FAT and SAT documentation, P&IDs, Maximo asset configurations, Tagged Component Lists (TCLs), Turnover Packages (TOPs), and IQ/OQ documentation for systems including ÄKTA chromatography and TFF skids, PUPSIT skids, mixing bag and temperature-control systems, pump carts, Sartorius BRX bioreactors, and Finesse Wave rocker/mixing platforms. Working closely with engineering, automation, vendors, commissioning, and qualification teams, this individual will identify documentation gaps, provide technical comments and approvals, track open items, and help maintain project timelines.

Role Accountabilities:

• Review Functional Specifications (FS) for technical completeness, automation accuracy, and alignment with User Requirements Specifications (URS), P&IDs, control narratives, and vendor documentation; provide review comments and approval/sign-off as appropriate.
• Support the limited closeout review of remaining URS documentation, identifying gaps or inconsistencies with process requirements, P&IDs, control narratives, and vendor specifications.
• Review FAT protocols and executed FAT records, confirming acceptance criteria trace back to the URS, FS, and functional requirements and ensuring deviations and vendor punch-list items are appropriately documented and dispositioned.
• Review SAT protocols and executed SAT records, verifying site-specific conditions and interfaces are adequately tested and that open items are tracked to closure before qualification.
• Review, redline, and approve P&IDs, verifying instrumentation, control loops, equipment tags, and alignment with associated engineering and vendor documentation.
• Apply working knowledge of Emerson DeltaV, Cytiva UNICORN, and OPC UA integration when reviewing documentation for chromatography, TFF, and other automated bioprocess systems.
• Review Maximo asset configurations, including asset hierarchy, tag naming, preventive maintenance templates, and spare-parts linkage, and confirm assets are properly configured before equipment turnover.
• Support the generation and completeness review of Tagged Component Lists (TCLs) and Turnover Packages (TOPs).
• Provide technical SME-level review and consultation for IQ/OQ protocols and executed records in support of qualification activities.
• Identify discrepancies across engineering, automation, validation, and vendor documentation and coordinate with the appropriate teams to support resolution.
• Maintain a document-review tracker showing review status, open items, blockers, approvals, and assigned change records.
• Provide weekly project updates on document-review progress, outstanding issues, and upcoming document volume.

Required Qualifications & Experience:

• Working knowledge of Emerson DeltaV architecture, control narratives, and module/phase logic, with the ability to critically review automation documentation without performing configuration or coding.
• Working knowledge of Cytiva UNICORN and its integration with DeltaV through OPC UA.
• Experience reviewing and approving FS, URS, FAT, and SAT documentation in a GMP-regulated biologics or pharmaceutical manufacturing environment.
• Ability to read, redline, and review P&IDs for automated bioprocess equipment, including instrumentation, control loops, and equipment tags.
• Experience with Maximo or a comparable computerized maintenance management system, including asset hierarchies, equipment records, preventive maintenance information, and spare-parts linkage.
• Knowledge of single-use bioprocessing equipment, such as chromatography and TFF skids, mixing bag and temperature-control systems, pump carts, bioreactors, and rocker/mixing platforms.
• Experience supporting validation and equipment-turnover documentation, including Tagged Component Lists, Turnover Packages, and technical review of IQ/OQ documentation.
• Experience identifying and resolving discrepancies across engineering, automation, vendor, and validation documentation.
• Familiarity with GMP change-control processes and electronic change-control or document-management systems.
• Strong technical writing, document-review, communication, and organizational skills.

Preferred Qualifications

• Previous experience supporting projects at a Single-Use Facility or a comparable biologics manufacturing site.
• Direct FAT or SAT witnessing experience with Cytiva, Sartorius, Finesse, or similar bioprocess-equipment vendors.
• Familiarity with ServiceNow or a comparable electronic change-control system.

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. These benefits include medical, dental, and vision, EAP, 401K, STD, LTD, AD&D, life insurance, paid parental leave, reward & recognition program and optional benefits including wellbeing benefits, adoption assistance and tuition reimbursement. 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.