The Maintenance Manager is responsible for managing the preventative maintenance and calibration program, lead equipment breakdown resolution, support technical aspects of quality investigations and drive resolutions, maintain equipment history and master data, support implementation of capital projects and support equipment and computer validation. The responsibility extends to ensuring that technical personnel are qualified to perform their duties and that the above responsibilities are properly documented and are conducted according to regulatory requirements, company guidelines and procedures such as cGMPs.
Responsibilities include but are not limited to:
- Provide leaderships within facility, vendors, contractors to assist "client" in achieving Quality, Productivity and Safety goals.
- Manage and execute the whole preventative maintenance program from start to completion and close.
- Ensure all facility and production equipment is properly maintained and up to date.
- Maintain proper files for all records and logbooks in compliance with cGMP, state, and federal guidelines.
- Organize and execute all major maintenance shutdown activities.
- Manage and execute the Calibration Program using BlueMountain.
- 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.
- Manage and review all service contracts on a regular basis.
- 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.
- Work closely with Engineering, Validation and the Health & Safety Committee to ensure Operations technical issues are being addressed to the required standards.
- 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 budget and manufacturing expense budget related to engineering and maintenance/calibration functions for following year.
- Prepare capital expense requests for submission for approvals.
- Monitor expenses for areas of control to adhere to approved budget.
- 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.
- Ensure correctness of master data, preventative maintenance plans and equipment history relative to production equipment and manage the equipment and facilities change control process.
- Maintaining controlled CAD facility and systems drawings.
- 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.
- Support equipment and critical systems validations.
- Prepare and review user requirements specifications.
- Write, review and approve operations and equipment SOPs.
- Remain current on industry and FDA engineering standards and trends.
- Any other duties as assigned.
Specific Skill Requirements:
- Minimum 5 years experience in Production and Packaging maintenance, combined with management, group or project management skills, preferably in the Food/Pharmaceutical industry.
- Strong knowledge of drug cGMP and cGDP.
- Experience in procurement, commissioning and qualification of manufacturing and packaging equipment.
- Experience with regulatory inspections.
- A Bachelor of Science degree in Mechanical or Chemical Process Engineering or equivalent trade.
- 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.
- 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.
The client is committed to fostering an inclusive, barrier-free and accessible environment. Part of this commitment includes arranging accommodations to ensure an equitable opportunity to participate in the recruitment and selection process. If you require an accommodation, we will work with you to meet your needs.