GMP Production Lead (Aseptic)

Merck Canada; Charlottetown; On-site; CAD 67,000 - 100,000; Full time

Job summary

Merck Canada is seeking a GMP-savvy operations professional to support veterinary biologics production on a defined schedule in Charlottetown, PEI. You will ensure compliant batch records, keep facilities and equipment in top condition, and train staff in GMP requirements.

You will lead operational excellence on the shop floor, balance production planning, scheduling, and shift coverage, and participate in investigations and CAPAs to uphold quality standards and site procedures.

Qualifications

• 3–5 years in a manufacturing setting with GMP experience preferred.
• Experience in aseptic fill/finish manufacturing is a plus.
• Supervisory or leadership experience is preferred.
• Experience writing deviations, CAPAs, SOPs and GMP docs.

Responsibilities

• Review and approve batch records and ensure sign-off by authorized personnel.
• Maintain qualified, validated, calibrated facilities and equipment; oversee cleaning and maintenance records.
• Lead operations with a focus on safety, quality, and cGMP adherence.
• Support production planning, shift coverage, attendance, and resource allocation.
• Conduct performance evaluations, coaching, and development with staff.
• Provide input to URS and support capital projects as needed.
• Escalate operational issues and drive continuous improvement.
• Ensure SAP transactions and material consumption are accurately documented.

Skills

GMP experience

Problem-solving

Team leadership

Quality systems

Investigations

Education

College Diploma in Life Sciences (Biochemistry/Chemistry/Biology/Eng)

Tools

MS Office

SAP

ERP systems

Job description

Merck Canada is seeking a GMP-savvy operations professional to support veterinary biologics production on a defined schedule in Charlottetown, PEI. You will ensure compliant batch records, keep facilities and equipment in top condition, and train staff in GMP requirements.

You will lead operational excellence on the shop floor, balance production planning, scheduling, and shift coverage, and participate in investigations and CAPAs to uphold quality standards and site procedures.