Maintenance & Calibration Lead

Job Title

Maintenance & Calibration Lead (Open)

Job Description Summary

• Reliability of all engineering assets onsite, providing maintenance and calibration support in all areas.
• Management of maintenance team including technicians assigned from facility management contractor.
• Dedicated owner and SME for all equipment external to the clean areas.
• Management of the calibration program and engineering safety programs.
• Provide SME support and participate in regulatory inspections.
• Management of vendor support for all systems on site.
• Management of engineering maintenance budget.

Roles and Responsibilities

The position requires effective cross functional collaboration with internal partners including Site Engineering, Facilities Management, Manufacturing Operations, Technical Operations, and Quality, and external contractors. The role ensures a commitment to safety, quality and operational excellence at a competitive cost. Responsibilities include understanding system reliability and availability, managing scheduled and unscheduled downtime, tracking engineering key performance indicators (KPIs), and managing maintenance and utility activities to meet manufacturing schedules while maintaining GMP compliance.

• Manage all maintenance engineering activities and utility activities, including planned and unplanned works on equipment.
• Manage preventative maintenance schedule and prioritize maintenance technician works across process and utility equipment.
• Cross train the process and utility technicians to utilise available resources to work in multiple areas.
• Manage and optimise the preventative maintenance program across process and utility systems, reviewing executed maintenance activities and identifying improvements.
• Develop and implement area / equipment improvement plans to repeat failures and other maintenance problems.
• Manage on call processes for engineering.
• Own and manage the financial aspects of the maintenance department, including budgeting, forecasting and cost tracking.
• Collaborate with site finance and project stakeholders to ensure maintenance and calibration services are delivered within approved budgets and identify cost saving opportunities.
• Provide regular financial updates to site leadership on budget expenditure and variances.
• Manage calibration program.
• Sponsor engineering safety programs within the maintenance and utilities structure - including hazardous energies, confined space, NDT/insurance inspections and pressure equipment directive.
• Deliver engineering commitments on regulatory programs associated with these assets, including AER, EPA, HSA, ISO certifications.
• Provide support to Manufacturing, Validation and Maintenance on process equipment and utility systems when required.
• Provide engineering expertise in troubleshooting activities to support manufacturing during process transfer activities or deviation investigations.
• Lead and support system improvements, development of specifications, engineering documents and standard operating procedures.
• Identify and support process optimisation initiatives and address opportunities for efficiency and capacity improvements in all areas of manufacturing support equipment.
• Research new processes and/or systems for maintenance/manufacture of equipment in conjunction with approved vendors and implement new processes and systems as developed under the direction of the Operations Manager.
• Advocate for engineering continuous improvement activities.
• Own equipment/systems in a GMP regulated manufacturing setting and lead troubleshooting and problem solving on process equipment, providing coaching and mentoring to other engineering, maintenance and operations staff.
• Lead technical root cause analysis, incident investigations and troubleshooting issues related to utility equipment/systems.
• Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
• Improve the engineering programs compliance, performance and reliability through technical knowledge and people leadership.

Experience, Qualifications and Education Requirements

• A third level degree in Process Engineering or a similar discipline.
• Minimum of 10 years of relevant experience working in a technical engineering management role in the pharmaceutical / biotechnology industry.
• Evidence of continuous professional development.
• Team leadership experience.
• Experience in identifying priorities for assignment of resources and time.
• Experience in the application of lean principles and structured problem solving techniques.

Competencies / Preferred Skills

• Strong technical capabilities, communication skills, teamwork abilities and initiative.
• Demonstrated ability to work effectively with vendors and resolve issues in a timely and structured manner.
• Organised analytical thinker with strong attention to detail.
• Excellent oral and written communication skills, including technical writing.
• Experience with management of department budget.
• Experience with engineering reliability optimisation programs.
• Must have good verbal and written communication skills.
• Ability to present and explain data to both technical and non technical forums.
• Collaborative teamwork philosophy and a demonstrated positive interaction with others.
• Mature judgement in problem solving situations.
• Independent decision making abilities with a strong results orientation mindset.
• Rigorous attention to detail.

EEO Statement

Keenova provides equal employment opportunities to applicants and employees without regard to race, color, gender, gender identity, sexual orientation, religions practices and observances, national origin, pregnancy, childbirth, or related medical conditions, protected veteran status, disability, or any other category protected by law.