Pioneer GMP Consulting
Process Engineer - Oral Solid Dose (OSD)
Pioneer GMP Consulting, Lexington, Massachusetts, United States, 02173
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.
Key Responsibilities
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.
Required OSD Technical Experience 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.
What We’re Looking For
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
Seniority level Mid‑Senior level
Employment type Contract
Job function Management and Manufacturing
Industries Pharmaceutical Manufacturing and Biotechnology Research
Referrals increase your chances of interviewing at Pioneer GMP Consulting by 2x.
Benefits Medical insurance
Vision insurance
401(k)
#J-18808-Ljbffr
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.
Key Responsibilities
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.
Required OSD Technical Experience 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.
What We’re Looking For
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
Seniority level Mid‑Senior level
Employment type Contract
Job function Management and Manufacturing
Industries Pharmaceutical Manufacturing and Biotechnology Research
Referrals increase your chances of interviewing at Pioneer GMP Consulting by 2x.
Benefits Medical insurance
Vision insurance
401(k)
#J-18808-Ljbffr