Senior Maintenance Technician
Bio-Life Plasma, LLC
Social Circle, GA
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Job Description
About the role:
The Senior Maintenance Technician reports to the Maintenance Supervisor and provides operational, maintaining and troubleshooting of process, utilities and electrical equipment that support the manufacturing process areas. Strict adherence to Standard Operating Procedures (SOPs), cGMPs, EHS and Quality Standards in a Pharmaceutical Manufacturing facility are mandatory. Primary responsibilities include ensuring safe and efficient hands-on maintenance of all manufacturing and utilities systems/equipment including Tanks, Mixers, Agitators, Centrifuges, Filter Presses, Filtration Skids, CIP Skids, Chilled Water, Industrial Water, WFI, RO, Fill and Packaging Equipment, Vessels, and components such as pumps, fans, valves.
How you will contribute:
Perform daily work order activities per Planning/Scheduling.
Ensure accurate documentation of PM, CM, and Emergent work order activities through adherence to GDPs.
Assist with troubleshooting of equipment issues including mechanical, electrical, metrology, or automation.
Support equipment IQ/OQ/PQ/Validation startup activities.
Support Reliability Centered Maintenance (RCM) activities to include Condition Monitoring and Infrared Technologies.
Perform assigned Metrology activities as assigned.
Assist and direct contractor/vendor activities as assigned.
Provide updates on work/projects to related teams (maintenance, mfg. etc..).
Familiarity with Change Control, Site, and Divisional SOPs related to position and department.
Procedural (JP’s, HECP’s, JHA’s, etc.) revision’s as necessary.
Strict adherence to EH&S guidelines and policies required to ensure compliance to Georgia state, federal EPA, and OSHA regulatory agencies.
Maintain two-way performance dialogue with your Supervisor to ensure mid, annual, and PDP processes are completed.
Demonstrate continuous personal pursuit to increasing job knowledge, proficiency in technical understanding, and problem-solving abilities.
Communicate concerns related to safe work practices, hostile work environment, sexual harassment, or any other type of employee misconduct directly to the Supervisor, Manager, or Human Resources.
Inspects, repair and maintains facility structures and equipment as directed by immediate supervisor and/or as assigned through work orders.
Support the manufacturing floor by aiding in setting up CIPs, COPs, and equipment LOTOs.
Perform preventive, corrective, and predictive maintenance through CMMS system.
Provide a moderate level of troubleshooting, diagnostic, and repair of process systems, equipment and equipment components which include valves, pumps, gearboxes, variable frequency drives, utility skids, cleaning equipment, support equipment (lifts, hoists, doors, carts, etc.)
All work must be completed following cGMPs, SOPs, job plans, and company policies.
Develop, revise, and review related SOPs or job plans/work plans for work related areas.
Provide input in the development and continuous improvement of the maintenance procedures.
Assist the maintenance supply team with maintaining an up-to-date working spare parts inventory system for the equipment/systems the team is responsible for.
Ensure that operational log and work order documentation is completed with accurate information.
Provide support of start-up of new equipment to ensure it meets all mechanical design specifications.
Develop a basic proficiency in one or more advanced maintenance technology and understand how to apply technology to improve equipment reliability (alignment, balancing, thermography, oil analysis, ultrasound, or vibration monitoring).
Provide support on start-up of equipment after completion of maintenance activities.
Provide support during calibrations with LOTO or setting up flow path on manufacturing equipment.
Minimum Requirements/Qualifications:
Typically requires high school diploma or GED. 2+ years of experience. Associates Degree in Engineering or Engineering technology desired but not required
Prefer 6 to 10 years combination of education, training, and experience in a cGMP related environment
Read and understand schematics and job blueprints.
Have mechanical knowledge of equipment, using P&ID’s, equipment manuals, specifications, SOPs, and be able to use proper judgment when taking corrective actions during equipment malfunctions.
Have or can gain knowledge of NFPA 70E electrical qualifications.
Have or can gain knowledge of FDA, OSHA, EH&S, EPA, and state of Georgia requirements.
Troubleshoot knowledge of miscellaneous equipment and process equipment and utilities (water systems, bulk delivery systems)
Have a basic understanding of control system to assist during troubleshooting.
Understand the concepts of Total Productive Maintenance and Operator Care
Other Job Requirements
May work in cold, wet environment; may be exposed to sunlight and heat; may be exposed to dust, gases, and fumes; may be around moving equipment and machinery; may climb up to and/or into large processing tanks for cleaning or inspection; may be working in areas requiring hearing protection and/or other protective equipment (PPE); may work around chemicals such as alcohol, acids and buffers that may require respiratory protection (PPE).
Must be able to work 12-hour shifts, either day or nights. May be required to work or be assigned to a different shift as needed. This position requires weekend and holiday work. Overtime may be required.
May be required to frequently kneel, stand, and walk to inspect, evaluate, and/or perform described maintenance activities.
What Takeda can offer you:
Comprehensive Healthcare: Medical, Dental, and Vision
Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
Health & Wellness programs including onsite flu shots and health screenings
Generous paid time off for vacation, sick leave, and volunteering
Community Outreach Programs and company match of charitable contributions
Family Planning Support
Professional development and training opportunities
Tuition reimbursement
Important Considerations
At Takeda, our patients rely on us to create quality products and we aim to create a safe environment for our team members. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product or putting anyone at the site in harm's way. In this role, you may:
Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
Work in a cold, wet environment.
Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
More About Us
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
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EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
