- Provide leaderships within facility, vendors, contractors to assist Bimeda in achieving Safety, Productivity, Quality, and Customer Service goals.
- Establish an environment that promotes communication at all levels and strives to make all information available when and where needed.
- Provide coaching to direct reports and develop them in both technical and leadership areas.
- Work closely with Engineering, Validation, and the Health & Safety Committee to ensure Operations technical issues are being addressed to the required standards.
- Support the technical aspects of quality investigations to determine the root cause of equipment related quality notifications and drive the associated corrective and preventative actions to complete.
- Manage to equipment and systems reliability and execute the whole preventative maintenance program from start to completion and close:
- Manage the Maintenance team to ensure compliance to preventative maintenance programs and availability of parts for maintenance, review history of breakdowns and upgrade equipment to prevent re-occurrences to improve equipment uptime
- Ensure all facility and production equipment is properly maintained and up to date.
- Manage and execute the Calibration Program using company-wide system/program.
- Ensure correctness of master data, preventative maintenance plans and equipment history relative to production equipment and manage the equipment and facilities change control process.
- Organize and execute all major maintenance shutdown activities.
- Manage and review all service contracts on a regular basis.
- Maintain proper files for all records and logbooks in compliance with cGMP, state, and federal guidelines.
- Write, review, and approve operations and equipment SOPs.
- Remain current on industry and FDA engineering standards and trends.
- Fill out and submit annual wastewater reports
- Work with EHS to maintain regulatory permits
- Maintains controlled CAD facility and systems drawings.
- Manage and responsible for building security including fire and theft alarms, issuing, and deleting employee building access, camera system and fire system.
- Manage control key system for all keys for the site.
- Prepare Capital Expense budget and manufacturing expense budget related to engineering and maintenance/calibration functions for following year.
- Assist in the development and management of the capital budget for the Operations area to ensure compliance and capacity improvement goals are achieved.
- Prepare capital expense requests for submission for approvals.
- Monitor expenses for areas of control to adhere to approved budget.
Competencies Required for the Role:
Leadership The right individual for this role will exhibit strong leadership capabilities. This person will have qualities that include optimism, compassion, self-motivation, and trustworthiness. We are looking for someone who can foster motivation, set clear and specific objectives, be a strong communicator and be a positive example to the team.
Time Management It’s important for the maintenance manager to excel in time management skills. A good time management professional will know how much time should be spent on each task and should know how to prioritize project duties in order to make deadline and eliminate downtime.
Technical Expertise Practical and technical expertise will enable the right individual to use their real-world knowledge to repair and fix problems. Ideally this expertise will have been learned in a pharmaceutical manufacturing or aseptic environment.
Problem Solving Skills A good problem solver needs to be able assess situations properly, make good judgement calls and act quickly. These skills will allow the maintenance manager to make the correct economic decisions, supervise staff, prioritize project tasks, create financial budgets, and create timelines.
Resiliency/Self Confidence –Measured confidence to take on demanding work or put forward views when they may be challenged. Stays calm in a crisis, or during time of change. Maintains performance and self-control under pressure or adversity. Handles competing demands and overcomes setbacks. Welcomes and learns from criticism.
- Minimum 5 years experience in Production and Packaging maintenance, combined with management, group or project management skills, preferably in the Food/Pharmaceutical industry.
- Working knowledge and understanding to operational impact of cGMP and cGDP within a pharmaceutical production facility.
- Experience in procurement, commissioning, and qualification of manufacturing and packaging equipment
- Experience with regulatory inspections and having accountability to representing Maintenance function.
- Thorough knowledge of mechanical engineering, electrical, electronic, and instrumentation systems.
- Strong ability to deal with ambiguity and manage through difficult situations.
- Demonstrated interpersonal savvy and relationship management/networking skills.
- Exercises innovative tactics and encourages others to demonstrate creative approaches, without compromise to regulatory compliance.
- Can read and understand a P&L to appreciate the impact to effective budget setting and management.
- Familiar with Cal-OSHA, Cal-EPA, LA County building and safety codes and regulations.
- Familiar with construction, electrical and plumbing practices.
- Familiar with Continuous Improvement and OOE principles and practices.
- Strong written and oral communication skills in English.
- A Bachelor of Science degree in Mechanical or Chemical Process Engineering or equivalent trade.
- Ability and speak and understand Spanish
- Experience working within company-wide information, documentation, and project tracking systems; such as but not limited to QAD, Blue Mountain, and ZenQMS.
Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.
Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a century’s experience in providing science-driven solutions to optimize the health, wellbeing and productivity of the world’s animals.
Bimeda’s global innovation program sees six state-of-the art R&D centers across four continents collaborate on an enviable product development pipeline which anticipates the ever-evolving needs of the animal health industry.
Bimeda’s nine manufacturing facilities across seven countries allow the company to manufacture a broad range of preventative, curative and nutritional products including sterile injectables, vaccinations, nutritional boluses, feed additives, tablets, water-soluble powders, pastes and non-sterile liquids.
Globally, the company focuses on the development, manufacture and commercialisation of quality Bimeda-branded products while also being the partner of choice for contract manufacturing and R&D services for prominent companies within the animal health industry.