Senior Principal Engineer, Equipment Prep & Start-up Lead

Biopharma Careers; Wilson (NC); In loco; USD 180.000 - 260.000; Tempo pieno

Descrizione del lavoro

Johnson & Johnson in Wilson, NC is seeking a Sr. Principal Engineer, Equipment Preparation Lead to drive end-to-end design and commissioning of the equipment preparation area for a new cGMP drug product facility.

You will lead cross-functional teams and coordinate with external vendors to ensure regulatory readiness. The role requires at least 10 years in process engineering or capital projects involving autoclaves, COP/SOP, and QA/QC, with strong problem solving, project management, and

Competenze

• Minimum of 10 years in process engineering or capital project execution for equipment preparation (autoclaves, parts washers, filter integrity testing, COP/SOP).
• Proven ability to lead multi-disciplinary teams and manage external partners.
• Strong knowledge of cGMP aseptic manufacturing and regulatory expectations.

Mansioni

• Develop and deliver specifications and drawings for equipment prep areas (URS, DS, P&IDs, PFDs).
• Assess vendor capabilities and manage bid review and project delivery.
• Lead FAT, SAT, C&Q activities and startup readiness for commissioning.

Conoscenze

Process engineering

Capital projects

Autoclaves

Parts washers

Filter integrity testing

COP/SOP

Disassembly & assembly

Stakeholder management

Regulatory compliance

Project leadership

Formazione

Bachelor's degree in engineering

MS or MBA preferred

Descrizione del lavoro

Johnson & Johnson in Wilson, NC is seeking a Sr. Principal Engineer, Equipment Preparation Lead to drive end-to-end design and commissioning of the equipment preparation area for a new cGMP drug product facility.

You will lead cross-functional teams and coordinate with external vendors to ensure regulatory readiness. The role requires at least 10 years in process engineering or capital projects involving autoclaves, COP/SOP, and QA/QC, with strong problem solving, project management, and