Job Description
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Position Details:
Title: Senior Maintenance Mechanic
Location: Hillsboro, OR
Shift: CWW (BE nights) / W-Fri w/ alternating Saturdays / 6PM – 6:30AM
Compensation: $80,000 - $90,000
Benefits: Full benefits package, extensive training, and participation in a company vehicle program, credit card and phone.
Travel: Local travel, to and from customers sites
Vaccine Requirement: Required
Position Description:
Under the direction of Mechanical Services Manager or other site leadership, perform a wide variety of tasks and operations that are required to formulate, fill, and inspect sterile pharmaceutical products in a state-of-the-art, automated production facility. In this role you will troubleshoot pneumatic, electrical systems, and mechanical equipment, including but not limited to pumps, heat exchangers, valves, gear boxes, steam traps, tanks, piping systems. You will maintain, and assemble all production equipment as required, lead, or assist on major equipment overhauls, repairs, and installations as necessary. Operations will be carried out in compliance with cGMPs, Standard Operating Procedures (SOPs), Work Instructions (WIs) and company’s standards. This is a night shift position.
• Support the maintenance, operation and repair of all systems, subsystems, and equipment within the Fill / Finish facility to include support to engineering and operations in the design, installation, testing, operation and maintenance of Fill Finish manufacturing and support equipment.
• Ensure all assigned equipment and associated subsystems are maintained in the following manner:
• All Preventative maintenance is performed at the appropriate interval and is completed by the assigned due date.
• All equipment remains in its designed and/or validated state at all times.
• All equipment operation is in accordance with Federal, State, Local and company’s regulations, procedures, and policies.
• Ensure / maintain all assigned equipment areas in a constant state of inspection readiness; specifically, but not limited to, the following:
• Cleanliness, Personnel and Equipment Safety, and Compliance to cGMP requirements
• Continuously improve associated SOPs, work instructions, engineering drawings, and various other controlled documentation for accuracy and applicability. Submit appropriate change requests to management to correct any deficiencies discovered.
• Provide training to maintenance technicians or other groups where applicable.
• Complete preventive maintenance and assigned paperwork in a safe and timely manner following all cGMP documentation guidelines.
• Coordinate contractors who perform repairs, modifications, and installations of various equipment.
• Perform Confined Space Entry on an as needed basis.
• Work in an FDA regulated environment directly with Manufacturing, Engineering and various Quality organizations on new system installations or modifications and maximize equipment availability.
• Must be able to install and rebuild various pumps, valves, mechanical seals and motors and have thorough working knowledge of shop tool operation and safety, cGMP compliance, pharmaceutical filling and inspection equipment operation, proper lubrication, maintenance and repair.
• Maintain and optimize mechanical drive trains and vacuum generation + distribution systems.
• Must continuously demonstrate the ability to work safely in an environment containing hazardous chemicals, high and low temperature liquids, high pressure liquids and gasses, steam, varying electrical voltages and moving machinery.
• Must have the ability to use Computerized Maintenance Management Systems and SOPs, understand P&ID’s, have basic computer skills using word processors, spreadsheets, databases, and email.
• Must be detail oriented, organized, capable of multitasking, and demonstrate good record keeping practices.
• Working knowledge of electrical switchgear and distribution systems in the medium to low voltage range.
Requirements:
• High School diploma or equivalent.
• 2 years related operation or manufacturing experience.
• 2 years progressive experience in manufacturing process control instrumentation, preferred.
• Technical degree, certificate, or completion of technical school coursework a plus.
• 8 to 12 plus years’ experience in the operation of complex mechanical equipment in an industrial / manufacturing maintenance/operation environment. Experience in pharmaceutical, biotechnology, biomedical, semiconductor, chemical, food processing, cosmetics, and/or other medical industries a plus.
• Demonstrates full ability to partner with and become a resource to customers. Anticipates, identifies, and defines needs and demonstrates ability to take ownership of customer’s problems.
• Ability to work overtime or temporarily modify shift schedule to support manufacturing operations as needed.
• Thorough working knowledge of Federal, State, Local and company’s regulations, procedures, and policies associated with industrial waste, bulk chemicals / gasses, refrigerants, and hazardous waste.
• Demonstrates full ability to identify and implement more complex process improvements within each functional group which improves inspection readiness, productivity, reduces time bound maintenance, or eliminates non-value-added activities. Ability to use project management skills to complete improvement projects by their due dates.
• Effectively work with minimum or no supervision.
• Ability to lift up to 50 pounds and be able to pass vision examination.
• Must be able to climb ladders and work at elevations up to 30 feet.
Company Description:
Our client is the founder of the biotechnology industry, is a company with a quarter-century track record of delivering on the promise of biotechnology. Today, are among the world’s leading biotech companies, with 12 protein-based products on the market for serious or life-threatening medical conditions and over 30 projects in the pipeline. With its strength in all areas of the drug development process - from research and development to manufacturing and commercialization - they continue to transform the possibilities of biotechnology into improved realities for patients.