Aseptic Process Engineering Lead for Biopharma

Blackfield Associates; North Carolina; On-site; USD 120,000 - 180,000; Full time

Job summary

Blackfield Associates are partnering with a global pharmaceutical manufacturer to recruit a Principle Process Engineer for a North Carolina-based, fulltime permanent role. You will provide technical leadership across design, commissioning and start-up of aseptic drug product systems and lead engineering deliverables and vendor management.

The role requires extensive experience in aseptic biopharma capital projects, strong cGMP knowledge, and coordination across cross-functional teams to meet

Qualifications

• Bachelor’s degree in Engineering (Mechanical or Chemical).
• Experience in aseptic biopharmaceutical capital projects.
• Proven experience leading design, installation, qualification and start-up of aseptic systems.
• Strong knowledge of FDA cGMP regulations and EU Annex 1.

Responsibilities

• Provide technical leadership for design, commissioning, qualification and start-up of aseptic drug product systems.
• Lead development of engineering deliverables: URS, PFDs, P&IDs, data sheets, specs.
• Oversee design and integration of aseptic systems including filling lines and isolators.
• Evaluate and manage equipment vendors, partners and contractors.
• Lead FAT, SAT, commissioning and qualification activities and readiness.

Skills

Process engineering

Capital project delivery

Aseptic manufacturing

Regulatory compliance

Cross-functional leadership

Education

Bachelor's degree in Mechanical or Chemical Engineering

Advanced degree preferred

Tools

Autoclaves

Single-use technologies

COP/SOP systems

Job description

Blackfield Associates are partnering with a global pharmaceutical manufacturer to recruit a Principle Process Engineer for a North Carolina-based, fulltime permanent role. You will provide technical leadership across design, commissioning and start-up of aseptic drug product systems and lead engineering deliverables and vendor management.

The role requires extensive experience in aseptic biopharma capital projects, strong cGMP knowledge, and coordination across cross-functional teams to meet