Bioprocess Project Engineer – GMP Documentation Lead

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 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.