Process Engineer - Oral Solid Dose; OSD

Process Engineer - Oral Solid Dose (OSD)

Pioneer GMP Consulting is seeking a Senior Process Engineer with deep Oral Solid Dosage (OSD) experience to support a large, long‑term pharmaceutical capital project in the Greater Boston area
. Resource:
Candidate Deck - Process Engineer | OSD

This role supports the design and build of a new OSD manufacturing facility and is embedded onsite with the client’s engineering team. The Senior Process Engineer will serve as a primary technical resource and equipment package owner
, supporting the project from early design through procurement, installation, startup, commissioning, and qualification.

This is a hands‑on, delivery‑focused role suited for an experienced OSD engineer who enjoys owning systems, working closely with site teams, and seeing major capital projects through to completion.

• Support the design and execution of an OSD manufacturing capital project
  , including a new facility build
• Serve as equipment package owner and primary technical resource for assigned OSD systems
• Develop and review URSs, equipment specifications, data sheets, and bid packages
• Act as a key technical contact for equipment procurement
  , from vendor selection through delivery
• Support facility and process design and coordinate closely with site engineering and automation teams
• Perform and support design reviews and risk assessments
• Drive equipment through installation, startup, commissioning, and qualification (CQV)
• Create and execute commissioning protocols and support validation protocol execution as needed
• Coordinate with equipment vendors and participate in FATs, SATs, vendor site visits, and onsite troubleshooting
• Maintain required GMP training and support documentation review and approval activities

The role is primarily onsite due to project demands, with occasional travel to vendor locations.

Candidates must demonstrate extensive project delivery experience within OSD manufacturing environments, including hands‑on ownership of:

• Isolators
• Downflow booths

Plus strong experience with at least one of the following:

• Wet and/or dry granulation systems
• Tablet compression systems
• Tablet coating systems
• Primary and/or secondary packaging lines

Experience supporting these systems through design, procurement, installation, startup, and qualification is required.

• 15+ years of experience in cGMP pharmaceutical manufacturing
  , with a strong focus on OSD
• Proven success delivering OSD capital projects in active manufacturing environments
• Strong understanding of equipment lifecycle management
  , cGMP requirements, and project execution
• Ability to work onsite and collaborate effectively with Engineering, Automation, Quality, and Operations teams
• Clear communicator with strong technical judgment and follow‑through
• Comfort operating as an embedded consultant within a client organization
• Location: Greater Boston area (Lexington, MA)
• Duration: Approximately 2 years (early 2026 through early 2028)
• Schedule: Full‑time, ~40 hours/week
• Travel: As needed for vendor and project activities

Mid‑Senior level

Contract

Management and Manufacturing

Pharmaceutical Manufacturing and Biotechnology Research

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Medical insurance

Vision insurance

401(k)