Production Supervisor - Fermentation / Superviseur(e) de production - Fermentation

Merck; Prince Edward Island; Vor Ort; CAD 70.000 - 95.000; Vollzeit

Zusammenfassung

Merck in Prince Edward Island is seeking an experienced GMP professional to support the production of veterinary biologics under cGMP guidelines. You will review batch records, ensure equipment and facilities stay qualified, and maintain hygiene standards while ensuring training is current.

The role includes leading investigations, managing change controls, and preparing GMP documents to meet site requirements. Strong communication and problem-solving are essential.

Qualifikationen

• Bachelor-level understanding of GMP and quality systems is required.
• Experience with batch records, deviations, CAPAs, and SOPs preferred.
• Leadership experience or supervisory exposure is an asset.

Aufgaben

• Review and approve completed batch records to ensure proper sign-off.
• Maintain facilities, equipment, and production areas in qualified state.
• Lead investigations and document Reliance events as needed.
• Prepare GMP documentation including SOPs and batch records.
• Support production planning and change control processes.

Kenntnisse

Project management

Quality systems

GMP knowledge

Problem solving

Communication skills

Ausbildung

College Diploma in Life Science

Tools

Microsoft Office

SAP/ERP

Jobbeschreibung

Job Description:

To support in the production process of veterinary biologics according to a defined production schedule following cGMP guidelines and specific Outlines of Production to meet market demands for aquaculture products.

Main Responsibilities and Duties

GMP Responsibilities:

• Review and approve completed batch records to ensure production records are evaluated and signed by an authorized person.
• Ensure facilities, equipment, and production areas remain in a qualified, validated, calibrated, and well-maintained state, including oversight of cleaning, maintenance activities, and associated records.
• Maintain plant hygiene standards and review relevant documentation, including logbooks.
• Ensure all team members receive and maintain required GMP training, including approval of instructor-led and on-the-job training (OJT).
• Ensure timely communication and escalation of quality issues through established processes.
• Initiate, classify, investigate, and document Reliance Events, serving as Lead Investigator when required.
• Act as Change Manager for changes impacting the department and ensure compliance with change control procedures.
• Prepare and revise GMP documentation including SOPs, master batch records, batch records, and other controlled documents.
• Ensure compliance with applicable GMP regulations, quality standards, and site requirements.
• May be delegated responsibility to temporarily perform the duties of the Operations Manager (IPT).
• Participate in required medical assessments in accordance with GMP regulations and site requirements.

Operations Responsibilities:

• Promote and model a "Safety First, Quality Always" culture and ensure compliance with all company safety, quality, cGMP, SOP, and manufacturing requirements.
• Ensure products are manufactured according to approved product dossiers and production requirements to meet business and market demands.
• Maintain a strong shop floor presence and provide leadership through technical expertise, problem-solving, continuous improvement, and process optimization.
• Act as the facility owner for assigned areas, taking accountability for operational performance and activities.
• Support production planning by providing input to schedules, monitoring execution, and tracking adherence.
• Manage shift coverage, short-term absences, attendance tracking, and workforce allocation.
• Conduct regular one-on-one meetings, performance evaluations, coaching, mentoring, and development discussions with direct reports.
• Build and maintain training plans to ensure work is performed by trained and qualified personnel.
• Ensure accurate and timely completion, review, and approval of production documentation, including batch records and SAP transactions such as material consumption.
• Investigate operational events using structured root cause analysis methodologies and document findings in Reliance.
• Implement operational improvements and minor process changes through established change control procedures.
• Provide input into User Requirement Specifications (URS) and support capital projects as required.
• Facilitate daily Tier 1 meetings and support Tier 2 management processes, including updating performance boards and facilitating meetings when required.
• Escalate significant operational issues and proposed solutions to the Operations Manager (IPT).
• Perform other duties as assigned.

Minimum Qualifications

Education:

College Diploma in a Life Science discipline such as Biochemistry, Chemistry, Biology, Chemical Engineering, or Biochemical Engineering preferred.

Experience:

• 3 to 5 years of experience in a manufacturing environment; GMP experience preferred.
• Experience in fermentation manufacturing preferred
• Previous supervisory or people leadership experience preferred.
• Experience conducting investigations, writing deviations, CAPAs, SOPs, and other GMP production documentation.
• Strong understanding of quality systems, cGMP requirements, and regulatory expectations.

Technical Skills:

• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint)
• Experience with SAP or other ERP systems preferred
• Experience in bacterial fermentation manufacturing preferred
• Strong written and verbal communication skills
• Excellent interpersonal and collaboration skills

Additional Requirements:

• Must be available on-call up to 12 hours per day, 7 days per week for emergency situations.
• Must be able to read, write, understand, and comply with applicable standard operating procedures.

This job posting is for an existing vacancy position .

We may use artificial intelligence and automated tools to support our recruitment process. AI tools are used to support, but not replace, human judgment. All hiring decisions are made by our hiring managers.

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