DSM Project Manager
- North America, United States
- Contract
- CAPEX Projects
Our client, a global pharmaceutical manufacturing organization are looking for a talented DSM Project Manager to join their expanding team. With continued organizational growth and considerable investment across their portfolio and capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility on the East Coast of the United States.
Essential Duties and Responsibilities for this role include, but are not limited to:
- Coordinate project execution with engineering design firm, FDBN CAPEX team, FDBN Automation process area owners, and system integrator.
- Manages delivery of specification documents (e.g., platform requirements specification (PRS), functional specification (FS), design qualification (DQ), etc.) and test protocols (e.g., installation qualification (IQ), operational qualification (OQ), etc.)
- Initiate design and provide input on Automation requirements for one or multiple process areas
- Manage/oversee the System Integrator’s support of loop checks & commissioning activities
- Provide on-call support to Commissioning, Qualification, Validation, and Operations activities.
- Coordinate with various project workstreams including FDBN Automation, FDBD Automation, CSV, CQV, Utilities, Process Engineering, Manufacturing, and others as needed
- Complete Safety, Project Procedure, and Project Instruction training as required
- Personal ownership and proactive collaboration with external business partners and internal stakeholders
- Direct experience working with Emerson DeltaV DCS & DeltaV MES
- Experience in a cGMP pharmaceutical facility working with FDA regulations is required
- Working knowledge of Kneat validation software is required
- Excellent organizational, oral, and written communication skills and fluency in English with the ability to effectively communicate within cross-functional teams and to management
- Excellent interpersonal skills and ability to work effectively and efficiently in a team-based environment with employees at all levels
- Ability to manage commitments while displaying an eagerness to learn and continuously improve
- Knowledge of Drug Substance Manufacturing (DSM) process
- ComplianceWire, TrackWise, and Veeva experience is a plus
If you are interested, please apply now for immediate consideration and further information.
#LI-NR1
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
Save as job alert
Similar Jobs
Salary
Competitive
Location
North Carolina
Salary
Competitive
Sector
CAPEX Projects
Job type
Contract
Location
North America
United States
Description
Drug Product Finished Goods Engineer - Pharmaceuticals - 12-Month Contract Our client, a global pharmaceutical manufacturing organization are looking for a talented Drug Product Finished Goods
Reference
35755
Expiry Date
01/01/0001
Author
Mark ChaumetonAuthor
Mark ChaumetonSalary
Competitive
Location
Dublin
Salary
Competitive
Sector
CAPEX Projects
Job type
Contract
Location
Ireland
Dublin
Description
Validation Engineer - Dublin, Ireland - 12 Months Contract Our client, a globally recognised pioneer in Biotechnology, are recruiting for the position of Validation Engineer. A leader in
Reference
36878
Expiry Date
01/01/0001
Author
Jack SteadmanAuthor
Jack SteadmanSalary
Competitive
Location
Cork
Salary
Competitive
Sector
CAPEX Projects
Job type
Contract
Location
Ireland
Cork
Description
Senior Buyer - Cork, Ireland - 12 Months Are you interested in joining a world leading biopharmaceutical company, focused on developing advanced and innovative treatments for those suffering with
Reference
36610
Expiry Date
01/01/0001
Author
Katarina ChalanskaAuthor
Katarina ChalanskaInsights
Send us your CV
Our candidates are the cornerstone of our organisation and we are always looking to connect with new professionals who are seeking their next contract assignment or career opportunity.
Narda
I manage this role.