Bulk Operations SME Consultant
BO_4376748027
Posted: 30/04/2026
- Philadelphia, Pennsylvania, United States
- Contract
Bulk Operations SME Consultant
Project Overview
A global biopharmaceutical manufacturer is delivering a large-scale bulk manufacturing CAPEX project ($1.5B) and is seeking an experienced Bulk Operations SME to support design review, CQV readiness, and transition to operations.
The role will provide specialist expertise across a complex bulk environment, including CIP systems, vessels, and filtration units, ensuring that design decisions support efficient commissioning, qualification, and operational readiness.
This project underpins long-term manufacturing capacity and network expansion. The bulk area is a critical path workstream, requiring additional specialist support due to overlapping projects and limited internal bandwidth.
Why This Role Is Needed
- Bulk workstream is operating with a lean internal team
- Multiple overlapping CAPEX projects are stretching internal SME capacity
- Additional external expertise is required to:
- Strengthen bulk design review
- Identify and mitigate downstream CQV risk early
- Avoid inefficient or sub-optimal design decisions
- Support a faster, more robust transition to operations
Key Responsibilities
- Act as a Bulk Operations SME during design and execution phases
- Support a large-scale bulk operation including:
- 20+ CIP skids
- 40+ vessels
- 6+ filtration units
- Perform detailed design and documentation review with a strong CQV lens
- Work with system owners and stream leads to:
- Identify design gaps and risks
- Influence design decisions to mitigate downstream CQV impact
- Collaborate closely with:
- Process engineering teams
- CQV teams
- Capital Project and QA stakeholders
- Provide practical SME input to:
- Reduce testing redundancy
- Improve CQV efficiency
- Accelerate progression to operations
- Support resolution of design exceptions prior to commissioning
Stakeholder Interaction
The consultant will be embedded within the project team and interface with:
- Bulk operations and process engineering stakeholders
- Engineering and design partner (IPS)
- CQV teams
- Capital Projects, QA, and Engineering leadership
Required Experience
- Senior-level Bulk Operations SME background
- Strong experience in:
- Bulk manufacturing environments (fractionation or comparable processes)
- CIP systems and cleaning skids
- Vessels and filtration systems
- Proven ability to:
- Understand design intent
- Identify downstream CQV impacts early
- Influence design decisions constructively
- Experience optimising designs to:
- Reduce CQV scope and redundancy
- Improve execution efficiency
- Protect project schedule
- Background working on large-scale CAPEX / new-build projects
- Comfortable operating in a lean, fast-paced project environment
- Practical mindset — focused on value and efficiency, not over-engineering
Working Model
- Hybrid working
- Approx. 50% on-site / 50% remote
- Example: two weeks on-site, two weeks remote
Travel & expenses
- Reimbursed in line with standard T&E policy
Why This Opportunity
- High-profile $1.5B CAPEX project
- Hands-on involvement in complex bulk systems at scale
- Opportunity to directly influence:
- Design decisions
- CQV strategy
- Operational readiness
- Hybrid working model with structured on-site engagement
- 5-6 year long term project
- Long-term opportunity as the project progresses and expands
Haider Tanveer
Principal Consultant
