Metrology Analyst - Talent Pipeline

Biovac; Cape Town; On-site; ZAR 420,000 - 720,000; Full time

Job summary

Biovac in Cape Town is seeking a Laboratory Equipment Maintenance Manager to oversee the execution, calibration and maintenance of QC lab instruments, ensuring compliance with cGMP and regulatory standards. You will coordinate with QC management, manage contractors, monitor SLAs and KPIs, and optimize maintenance schedules to prevent downtime.

The role requires a Diploma/Degree in a relevant science or engineering field and 3–5 years of metrology/asset management experience in pharma.

Qualifications

• Requires Diploma or Degree in Microbiology, Biochemistry, Chemistry or Engineering.
• Minimum 3–5 years of metrology, instrument calibration, or asset management in pharma/biopharma/medical devices.

Responsibilities

• Oversee calibration, maintenance and qualification of lab equipment.
• Interact with QC management to ensure timeliness and availability.
• Manage contractors and monitor SLA/KPIs.
• Ensure regulatory compliance and data integrity in audits.
• Plan daily and weekly activities and budgets.

Skills

Project management

Equipment maintenance

Quality & compliance

Data analysis

Documentation

Education

Diploma/Degree in Microbiology/Biochemistry/Chemistry/Engineering

Tools

CMMS

Pragma

OEM systems

Job description

Job purpose

• Manage the execution of all laboratory equipment, sourcing, qualifying, maintenance, calibration, compliance activities and adherence to specified timelines, including any deviations to work schedules
• Ensures the repair of laboratory equipment timeously according to policies and procedures
• Facilitate interaction with QC laboratory management team to ensure equipment is maintained and calibrated according to procedures, on time and available for use.
• Escalate all failures to the QC management timeously.
• Oversee contractors in the execution of activities
• Monitor contractor adherence to SLA and KPI’s
• Manage resources to execute plans and monitor schedule compliance
• Ensure safe and efficient execution of required activities
• Enforce legal compliance of maintenance operations
• Ensure tools, assets, controls are within required guidelines and standards
• Ensure stock levels are maintained to prevent out-of-stock situations (calibration standards, spare parts, etc)
• Ensure weekly routine maintenance schedule is executed as planned/scheduled
• Ensure continual compliance of laboratory standards and SOPs to latest pharmacopeial, and regulatory compliance
• Continually improve and optimize work processes
• Provide input into operational planning and prioritization of section objectives
• Provide input into budgets & resource requirements for section
• Ensure Capex management for the QC laboratory equipment is based on needs and business objectives.
• Participate in development of work schedules
• Participate in sourcing (URS/UB), purchasing, receipting DQ/IQ/OQ/PQ of all new equipment.
• Participate in all requalification activities with support functions.
• Actively Participate in Laboratory investigations and problem solving where equipment is impacted
• Ensure that all data generated are reviewed and released according to cGMP and data integrity policies and procedures
• Ensure all documentation generated is retained and easily available during audits
• Plan daily and weekly activities
• Provide coaching and supervision for technicians/analysts when required
• Manage and execute priority work orders/ jobs when necessary
• Perform maintenance/calibration/trouble shooting on all QC Laboratory Equipment
• Liaise with QC Laboratory and Engineering to ensure that the maintenance plan is accommodated
• Liaise with suppliers during trouble shooting/OOS/OOT on all laboratory equipment in attempt to find and correct root causes.
• Co-ordinate problem solving and priorities execution of tasks
• Ensure that jobs are properly completed and closed on time
• Provide input for improvement of risk-based compliance systems
• Monitor implementation and correct own and/or team compliance with the current regulations and guidelines - both local and international

Minimum qualification(s)

• Required:
• Diploma/Degree in Microbiology/Biochemistry/Chemistry/Engineering or equivalent
• Preferred:
• Recognition is given to Prior Learning and practical experience.

Experience & industry knowledge

• Required:
• Minimum 3–5 years of experience directly performing metrology, instrument calibration, or asset management within a pharmaceutical, biopharmaceutical, or medical device laboratory.
• Experience in quality and regulatory compliance within a cGMP in Sterile/Vaccine facility
• Participation in monitoring expenditures for Expense Budgets and Capex related costs
• Preferred:
• Working knowledge of Pharmaceutical Manufacturing related legislation
• Experience in aseptic (sterile) manufacturing within a QC Laboratory

Technical Competencies required to perform this aspect of the role:

• Excellent understanding and working knowledge of Pragma/CMMS and OEM systems.
• Detailed knowledge of pharmaceutical industry standards and guidelines in GMP
• Documentation Management
• Inventory Management
• Environmental, Health & Safety Management
• Statistical Trending & Data Analysis
• Metric Development & Report Writing
• Coaching & Mentoring of peers & staff
• Review & Auditing Skills
• Compliance and process driven
• Customer awareness
• Communication: Effective verbal and written communication skills for interfacing with suppliers and internal teams
• Organization: Strong capability to manage multiple tasks and prioritize according to due dates and project timelines. Excellent
• Document control

Business Management

• Shared accountability for achieving the site’s tactical plans and mitigation of any risk to the site operation including workflow, ethics, quality, finances, regulatory compliance and other material company requirements.
• Identify and continuously present key opportunities and synergies that will improve and/ or expand the operation within own and/ or other departments.
• Participate in departmental and/ or site wide projects
• Monitoring & reporting on key operations, critical numbers and key performance indicators that impacts the business’s short, medium and long term objectives.
• Participate with the site management team in proactively mitigating risks and find solutions where possible
• Effective and comprehensive costing, budgeting and expense management, taking all overlapping site activities into consideration.

Core Technical Delivery

• Ensures that the Laboratory Maintenance/calibration schedule is maintained
• Manage and execute priority work orders/ jobs when necessary
• Ensures that calibration and preventative maintenance of lab equipment is performed according to SOPs
• Ensures that faulty lab equipment is repaired within set timelines and according to policies and procedures
• Ensures OOS, OOT and OOE results are investigated according to set procedures

Quality Management

• Building own, team and site’s GMP Knowledge and Compliance
• Participate in building quality objectives and provide ongoing metrics that directly support the achievement of such objectives.
• Participate in building a sustainable Quality Culture on site and proactive mitigate risks that may negatively impact quality or elevate these appropriately.
• Establish and maintain a state of control related to quality management within the department
• Ensuring that the department is audit ready through closing out audit findings timeously
• Ensure Deviations, Change Controls, CAPAs are handled effectively
• Advocate continuous improvement within own department as well as cross functionally

Technical Competencies required to perform this aspect of the role:

• cGMP vaccine manufacturing- quality and regulatory compliance knowledge, i.e. MCC and WHO
• Advanced knowledge of methods, practices, techniques and equipment used in laboratory, maintenance and repair
• Working Knowledge of laboratory processes, procedures and maintenance activities
• Knowledge of pharmaceutical manufacturing, standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives