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System Start Up Readiness Lead
Job in
Indiana Borough, Indiana County, Pennsylvania, 15705, USA
Listed on 2026-08-22
Listing for:
Blackfield Associates
Full Time
position Listed on 2026-08-22
Job specializations:
-
Engineering
Quality Engineering, Pharma Engineer -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
Contract:
12 months, with likely extensions
We are looking for an experienced System Start-Up Readiness Lead to support the transition of systems and equipment from Construction/CQV into Operations.
Key Responsibilities:- Lead operational readiness, start-up and system handover activities.
- Coordinate between Engineering, CQV, Quality and Operations
. - Develop and manage system start-up and readiness plans.
- Lead PSSR activities and coordinate pre-start-up requirements.
- Ensure operational documentation, SOPs, manuals and training are ready for handover.
- Coordinate knowledge transfer, vendor walkthroughs, SAT and operational training.
- Manage turnover packages and system ownership transfer into Operations.
- Support initial start-up, troubleshooting and early operational activities.
- 10+ years’ experience within pharmaceutical operations
. - Strong experience with capital projects, facility start-up and system turnover
. - Solid understanding of CQV, GMP, utilities, manufacturing systems and equipment
. - Proven ability to work across Engineering, CQV, Quality and Operations teams.
- Strong stakeholder management and communication skills.
- Engineering or relevant technical degree preferred.
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