Manufacturing Operations Leader, Pharma & Devices

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); On-site; USD 100,000 - 170,000; Full time

Job summary

PCI Pharma Services in the United States seeks a Manufacturing Manager to lead all aspects of site operations, including aseptic filling, lyophilization, and packaging, ensuring cGMP compliance and on-time product delivery.

You will supervise Manufacturing Technicians, manage budgets, drive process improvements, and collaborate with Quality, Validation, Facilities and Project Management to meet client needs.

Qualifications

• BA science degree and 5+ years of pharma or medical device manufacturing experience.
• Proven aseptic process leadership experience.
• Understanding of cGMP and WW regulatory requirements (e.g. EU) for parentals or experience in ISO 5/6 areas.
• Gowning experience necessary.
• Knowledge of contamination control and aseptic technique; training is beneficial.

Responsibilities

• Manage and direct staff to ensure continuous function of all manufacturing operations and schedules.
• Lead safety initiatives and ensure compliance with PCI safety procedures.
• Ensure cGMP and regulatory guidelines are followed in cleanroom areas.
• Coordinate production schedules, staffing, planning activities, and equipment maintenance.
• Direct personnel to complete batch records and SOP documentation.
• Review and approve investigations, OOT/OOS, EEIs and deviation reports; change controls and CAPAs.
• Coordinate validation protocols and other process studies.
• Support process enhancements and new product development projects.
• Oversee training of operators in aseptic technique and packaging procedures.
• Collaborate with Validation, Facilities, Quality, Project Management and Senior Management.

Skills

Staff leadership

Aseptic process knowledge

cGMP compliance

Project management

Education

BA in science

Job description

PCI Pharma Services in the United States seeks a Manufacturing Manager to lead all aspects of site operations, including aseptic filling, lyophilization, and packaging, ensuring cGMP compliance and on-time product delivery.

You will supervise Manufacturing Technicians, manage budgets, drive process improvements, and collaborate with Quality, Validation, Facilities and Project Management to meet client needs.