Process SME
- England, North West
- Contract
- Life Sciences
How would you like the opportunity to work with in one of the largest biopharmaceutical projects in the world? If yes, then this is the assignment for you!
Our client is currently seeking the skills of a Process SME to join their team. Our client develops and delivers life changing medicines to millions of people globally and as part of their growth. With their Drug Substance (DS) manufacturing network growing rapidly, they are committed to growing their portfolio of commercial biologics products supplied worldwide – and this is your opportunity to be involved!
Experience:
- Understand business objectives, project scope, schedule, and critical success factors
- Understand and engage project stakeholders relevant to SME role
- Ensure requirements are appropriately documented and agreed with project stakeholders
- All GMP URS should be documented and agreed with project stakeholders in basic design
- Work collaboratively with project stakeholders
- Note: this includes collaboration between other packages and disciplines
- Ensure requirements are understood and included in the scope of works of designer
- Proactive engagement with designer to ensure design is being developed in line with requirements
- Support work package owners in understanding requirements and design basis
- Consulted on work package breakdown and scope of works
- Attendance to project meeting, design meetings, SME meetings, and project tier meetings, as agreed with PTM.
- Raise issues and escalate through agreed project processes
- Input into project risk register and project/work package cost/schedule reviews
- Responsible for design assurance reviews for assigned technical packages
- Consulted on C&Q plan
- Input into SHE risk assessments
- Reporting of progress, issues, and escalations to ETS tier process
- Review design deliverables to validate that they meet requirements
- Prepare for and participate in PDRI
- Support PTM in preparation for Engineering Council
- Prepare requirements for Detailed Design
Skills/requirements:
- Bio Process background
- Design experience
- Vendor / Stakeholder management
- Must be self-sufficient and able to operate independently.
- Strong understanding of automation team interactions and systems integration.
Interested in this role? Apply today!
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
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
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
WE’RE NOT JUST
ABOUT THE WORK
Although That’s Pretty Awesome
We’re about an unmatched company culture and a huge range of benefits you’ll love, both on and off the clock.
Check out all our perks hereSimilar Jobs
Salary
Competitive
Location
Milan
Salary
Competitive
Sector
Commissioning, Qualification and Validation
Job type
Contract
Location
Italy
Description
Commissioning Manager - Italy - 12-Month Rolling Contract This is your opportunity to work for a global data centre operator that has been recognised for as one of fastest growing and well-known
Reference
36397
Expiry Date
01/01/0001
Author
Charlotte ClarkeAuthor
Charlotte ClarkeSalary
Competitive
Location
Illinois
Salary
Competitive
Sector
CAPEX Projects
Job type
Contract
Location
North America
United States
Description
Project Controls Professional - Illinois, United States - 12 Months Contract This is a fantastic opportunity for a Project Controls Professional to join our major, global pharmaceutical client
Reference
36341
Expiry Date
01/01/0001
Author
Kristen ScottAuthor
Kristen ScottSalary
Competitive
Location
North Carolina
Salary
Competitive
Sector
CAPEX Projects
Job type
Contract
Location
North America
United States
Description
Site Safety Lead - North Carolina - 12 Months Contract Our client, a globally recognized pioneer in Biotechnology, are recruiting for the position of Site Safety Lead. A leader in the industry,
Reference
36358
Expiry Date
01/01/0001
Author
Davis AtkinsonAuthor
Davis AtkinsonInsights
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.
William
I manage this role.