System Start Up Readiness Lead

Blackfield Associates; Indiana (PA); On-site; USD 120,000 - 180,000; Full time

Job summary

Blackfield Associates is seeking a System Start-Up Readiness Lead to drive the transition of systems and equipment from Construction/CQV into Operations. You will lead operational readiness, start-up and system handover, coordinating between Engineering, CQV, Quality and Operations.

The role demands 10+ years in pharmaceutical operations, strong experience with capital projects, facility start-up and system turnover, and a solid understanding of CQV, GMP, utilities and manufacturing systems.

Qualifications

• 10+ years of experience in pharmaceutical operations.
• Experience with capital projects, facility start-up and system turnover.
• Strong understanding of CQV, GMP, utilities, manufacturing systems and equipment.

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.

Skills

Operational readiness

Cross-functional collaboration

Stakeholder management

Communication

Training coordination

Education

Engineering degree

Job description

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.

Ideal Candidate:

• 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.