P
Commissioning Engineer
Accepting applicationsPragmatic · North Carolina, United States
Full-Time Mid_senior aiarmatesoc
Posted
1d ago
Category
Test
Experience
Mid_senior
Country
United States
CQV Engineer – Upstream Processing
Contract | North Carolina | On-Site
Are You a CQV Engineer With Experience on Major Projects?
If you are an experienced CQV Engineer thinking about your next contract move, we'd love to have a conversation now so we can move quickly when the time is right.
We are working with a key client on a large-scale biopharma capital programme in North Carolina and are keen to speak with strong upstream candidates ahead of requirements being confirmed.
About the Role
A CQV Engineer to be embedded within a large-scale biopharma project team, taking full ownership of commissioning, qualification and validation activities across upstream processing. You'll work within a multi-disciplinary team on a Tier 1 client site, through Pragmatic Resource.
What You'll Be Doing
Commissioning and Qualification
Execute C&Q activities across upstream systems from IQ through to PQ
Work alongside the project team to ensure activities are planned, documented and delivered on schedule
Validation
Author, review and execute validation protocols and reports in line with GMP requirements
Support risk-based validation approaches in line with ASTM E2500 and ICH Q9/Q10
Technical and Compliance
Ensure all deliverables meet FDA, EMA and ICH requirements
Manage deviations and maintain accurate documentation throughout
Stakeholder Collaboration
Liaise with manufacturing, quality and engineering teams to support smooth system handover
Support punch list management, scheduling and closeout across the wider C&Q team
What We're Looking For
Experience
3 to 7 years of CQV experience within pharmaceutical or biopharmaceutical manufacturing
Hands-on experience in upstream processing, covering bioreactors, media preparation, seed train and associated utilities
Capital project or greenfield/brownfield facility experience a strong advantage
Technical
Solid understanding of upstream GMP equipment, facilities and utilities
Familiar with FDA, EMA and ICH regulatory requirements
Competent in protocol authoring, deviation management and technical report writing
Personal
Detail-oriented and methodical with the ability to manage your own workload on a busy project site
A team player comfortable working across disciplines
Contract Details
Location: North Carolina, fully on-site
Position: One upstream CQV Engineer
If your CQV background covers upstream biopharma and North Carolina is on your radar, get in touch now and let's have a conversation.
Show more Show less
Contract | North Carolina | On-Site
Are You a CQV Engineer With Experience on Major Projects?
If you are an experienced CQV Engineer thinking about your next contract move, we'd love to have a conversation now so we can move quickly when the time is right.
We are working with a key client on a large-scale biopharma capital programme in North Carolina and are keen to speak with strong upstream candidates ahead of requirements being confirmed.
About the Role
A CQV Engineer to be embedded within a large-scale biopharma project team, taking full ownership of commissioning, qualification and validation activities across upstream processing. You'll work within a multi-disciplinary team on a Tier 1 client site, through Pragmatic Resource.
What You'll Be Doing
Commissioning and Qualification
Execute C&Q activities across upstream systems from IQ through to PQ
Work alongside the project team to ensure activities are planned, documented and delivered on schedule
Validation
Author, review and execute validation protocols and reports in line with GMP requirements
Support risk-based validation approaches in line with ASTM E2500 and ICH Q9/Q10
Technical and Compliance
Ensure all deliverables meet FDA, EMA and ICH requirements
Manage deviations and maintain accurate documentation throughout
Stakeholder Collaboration
Liaise with manufacturing, quality and engineering teams to support smooth system handover
Support punch list management, scheduling and closeout across the wider C&Q team
What We're Looking For
Experience
3 to 7 years of CQV experience within pharmaceutical or biopharmaceutical manufacturing
Hands-on experience in upstream processing, covering bioreactors, media preparation, seed train and associated utilities
Capital project or greenfield/brownfield facility experience a strong advantage
Technical
Solid understanding of upstream GMP equipment, facilities and utilities
Familiar with FDA, EMA and ICH regulatory requirements
Competent in protocol authoring, deviation management and technical report writing
Personal
Detail-oriented and methodical with the ability to manage your own workload on a busy project site
A team player comfortable working across disciplines
Contract Details
Location: North Carolina, fully on-site
Position: One upstream CQV Engineer
If your CQV background covers upstream biopharma and North Carolina is on your radar, get in touch now and let's have a conversation.
Show more Show less