GMP Manufacturing Support Lead — Process Excellence

BioSpace; Petersburg (VA); On-site; USD 70,000 - 90,000; Full time

Job summary

BioSpace in Petersburg, VA is seeking a Manufacturing Support Lead to guide daily operations and provide frontline leadership for manufacturing associates. The role emphasizes equipment qualifications, process improvements, and compliant production aligned with FDA/cGMP standards.

Responsibilities include mentoring staff, maintaining documentation, and coordinating across shifts to ensure continuous, safe, and efficient production.

Qualifications

• 3+ years of Operations or Manufacturing Support in Pharmaceuticals (cGMP, FDA-regulated, ISO).
• Experience with autoclaves, parts washers, and manufacturing support equipment.
• Team lead or trainer experience in GMP manufacturing environment preferred.
• Lean Manufacturing and Six Sigma knowledge preferred.
• Strong documentation and communication skills.
• Self-directed with strong problem-solving and analytical abilities.
• Ability to collaborate across departments and shifts.

Responsibilities

• Provide daily direction to Manufacturing Associates during routine operations.
• Act as SME for manufacturing support processes including autoclaves, washers, CIP, and MTIs.
• Support equipment qualification, commissioning, validation, and startup activities.
• Serve as primary point of contact for operational issues and escalate concerns when needed.
• Assist with inspections, audits, and corrective actions.
• Ensure personnel are trained and qualified prior to activities.
• Support SOPs, batch records, and governing documents.
• Promote compliance with FDA, cGMP, ISO, safety requirements.
• Identify and implement Lean improvements.
• Mentor and train associates on processes and documentation.
• Coordinate shifts and departments for continuity.

Skills

Team leadership

Regulatory compliance

Problem solving

Communication

Cross-functional collaboration

Lean manufacturing

Documentation practices

Education

High school diploma or equivalent

Tools

Autoclaves

Parts washers

CIP systems

MTIs (material transfer isolators)

Job description

BioSpace in Petersburg, VA is seeking a Manufacturing Support Lead to guide daily operations and provide frontline leadership for manufacturing associates. The role emphasizes equipment qualifications, process improvements, and compliant production aligned with FDA/cGMP standards.

Responsibilities include mentoring staff, maintaining documentation, and coordinating across shifts to ensure continuous, safe, and efficient production.