Sr. Maintenance Mechanic - United States
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- Our company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
- We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
- These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.
- Our company will continue to focus on advancing therapies that are the first or best of their kind.
- By providing a foundation for all operations company wide, our company’s General and Administrative teams support our mission of providing first and best in class therapeutics to patients who live with rare diseases.
- Our teams include groups such as finance, legal, human resources, corporate compliance and ethics, and information technology. Come join our team and make a meaningful impact on patients’ lives.
- The Sr. Maintenance Mechanic is accountable for performing Preventive Maintenance and repair work orders in the manufacturing facility.
- The position requires strong mechanical knowledge and troubleshooting skills on utility and process systems involved in making drug product.
- The individual will work closely with manufacturing technicians and supervisors to provide excellent customer when repairs are required within the manufacturing suites. The Sr. Mechanic must exhibit a strong sense of cross-functional teamwork and collaboration and have a strong skill set to communicate effectively with management. The Sr. Mechanic will also be an active member of the company Emergency Response Team (BERT).
- Execute PM and general work orders, i.e., hands on position (approximately 80%). Ensure all assigned PM’s and WO’s are completed in a timely manner.
- Work in a clean room environment. Perform preventive maintenance and repair orders on process equipment.
- Identify mechanical malfunctions and implement complex corrective actions.
- Perform PM's on Manufacturing Process equipment as well as corrective work orders.
- Ensure planned inspections of facilities equipment and services are performed. Take actions as needed.
- When required, complete Shift Pass Down Form to assure adequate review of alarms or other operating conditions or instructions for incoming shift.
- Lead Mechanics on various projects including plumbing, electrical, and mechanical.
- Red line or write Standard Operating Procedures when required.
- Perform troubleshooting, evaluation, and repair of complex equipment and process control systems.
- Assist in completion of Quality Assurance Change Requests.
- Help coordinate department activities with the Facilities Planner as necessary for manufacturing process equipment maintenance.
- Coordinate with outside contractors as necessary. Assure contractor compliance with EH&S requirements (waste disposal, hot work permits, confined space, LOTO, etc., Contractor Technical Certifications program CTC, and Utility Training Certification Program UTC).
- Maintain detailed and accurate records as necessary in order to maintain GMP and department procedure compliance.
- Provide validation execution assistance.
- Lead Mechanics and Senior Mechanics in start-up of new mechanical systems.
- Train other mechanics for mechanical repair and maintenance.
- Participate in teams and upkeep of data elements for the Computerized Maintenance Management System (CMMS).
- Participate on the company Emergency Response Team (BERT).
- Other projects/tasks as assigned by supervisor or management.
- 4+ years of experience in a Biotech cGMP maintenance environment or Journeyman level in a trade relevant to the position.
- Proficient in MS office
- Proficient written and verbal communication at all levels is required.
- Experience in the following systems desired:
- Water systems
- City water supply
- RO / DI Purified water generation and distribution
- WFI generation and distribution
- Plant steam boilers
- Pure steam generators
- Compressed gases
- Waste water treatment systems
- Experience working with process skids such as:
- Chromatography Skids
- UF/DF Skids
- TFF Skids
- Water systems
- High school diploma is required
- College degree or Trade school.