Browse by job sector

Process SME

  1. England, North West
Manchester
  1. Contract
Competitive
  1. Life Sciences
36219
Apply to this job Save job
Process SME - Life Sciences - 12-month contract - Manchester

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! 

Apply to this job Save job
Save as a job alert
List #1

Similar Jobs

Full Stack Developer

Salary

€55 - €70 per annum

Location

County Dublin

Salary

up to £35,000

Sector

CAPEX Projects

Job type

Permanent

Location

North America

United States

Description

Full Stack Developer - Dublin, Ireland - Permanent We have an exciting job opportunity for a Full Stack Developer to join our client, one of Europe’s leading engineering experts and

Reference

36636

Expiry Date

01/01/0001

Mark Chaumeton

Author

Mark Chaumeton
Mark Chaumeton

Author

Mark Chaumeton
Read more
Read more
Electrical Lead

Salary

Competitive

Location

Munich

Salary

Competitive

Sector

CAPEX Projects

Job type

Permanent

Location

Germany

South Germany

Description

Electrical Lead - Munich, Germany - Permanent Our client is at the forefront of advancing health care. Their mission is to discover, develop, and deliver innovative care solutions that improve

Reference

36605

Expiry Date

01/01/0001

Peter Hallam

Author

Peter Hallam
Peter Hallam

Author

Peter Hallam
Read more
Read more
CQV PLC Support Engineer

Salary

Competitive

Location

North Carolina

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

North America

United States

Description

CQV PLC Support Engineer - North Carolina, United States - 8 Months Rolling Contract Our client, a global pharmaceutical manufacturing organization are looking for a talented CQV PLC Support

Reference

36635

Expiry Date

01/01/0001

Mark Chaumeton

Author

Mark Chaumeton
Mark Chaumeton

Author

Mark Chaumeton
Read more
Read more

Insights

Living and working in Ireland
Read more

03/12/2025

QCS Staffing | What does a commissioning manager do?

What does a Commissioning Manager do?
Read more

02/20/2025

Day In the Life of a Commissioning Engineer Jobs

Day in the Life of a Commissioning Engineer

Read more

11/03/2024

VIEW ALL

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.

Send your CV
Upload your CV