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Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. JOB SUMMARY The Maintenance Technician III performs preventative and corrective maintenance with minimal supervision on process, Facilities, equipment and utilities such as clean steam, Purified water, Water for Injection (WFI) preventive maintenance of a wide range of mechanical equipment and piping systems including, but not limited Freeze Dryers, Fill Finish equipment and clean utilities. Other equipment to include agitators/mixers, autoclaves, parts washers, and various sanitary design pumps and valves within a cleanroom environment. Further duties may include performing preventative and corrective maintenance to complex utility systems which may include Heating Ventilation and Air Conditioning (HVAC), plant steam, refrigeration, plumbing, electrical, compressed air and gases, and/or other Biotech/pharmaceutical utilities. This position works closely with Engineers, Technicians, and Manufacturing personnel. JOB DUTIES
Responsibilities include, but are not limited to Promote a safe working environment by following all LSNE safety procedures. Perform highly diversified duties like install, troubleshoot, repair and maintain utilities, production, and facility equipment in accordance with the site safety principles, predictive, and production maintenance systems and processes in order to achieve the site's goals and objectives. Performs defined PM activities under minimal supervision, may provide guidance to other peers and junior Facilities Maintenance team members. Proactively Conduct routine inspections to ensure no adverse events have occurred around the FSUE and to keep the facilities equipment and utilities in inspection/audit ready state. Provide troubleshooting, repair and maintenance services for production related systems and components including high vacuum, process water, cooling, hydraulics, pneumatics, remote and PLC/HMI interfaces.*Operates and monitors advanced equipment and utilities, maintain spare parts for uptime. Executes basic maintenance activities, Supports the installation of new equipment under limited supervision. Revise and review existing maintenance and utility system procedures (SOPs). Trains other technicians on basic and advanced maintenance and equipment operation. Coordinates maintenance activities including repair work and PMs with cross functional teams. Participate in on-call or emergency response 24/7 rotation with minimal supervision. Supports and directs on-site service contractors and vendors. Perform preventative, routine, and non-routine maintenance on GMP equipment. Respond to critical alarms for equipment systems; investigate equipment failures and serves as system expert for troubleshooting and repairs.
PROFESSIONAL SKILLS
Must be a self-starter and comfortable working in an ambiguous environment. Have ability to read, interpret, and troubleshoot engineering drawings, piping and instrumentation diagrams, and mechanical schematics/equipment repair manuals. Basic understanding of computer programs such as Microsoft Outlook, Word, Excel. Must be able to work in a team environment as well as independently. Prior experience using a CMMS system as a work tracking and maintenance documentation system.
EXPERIENCE
- 5-10 years previous maintenance/engineering experience, minimum of 2 years previous experience in a GMP and/or cleanroom facility preferred.
- Ability to trouble shoot, diagnose and repair manufacturing equipment for product lines, with assistance from higher-level technician.
- Experience with hazardous energy isolation and lock-out/tag-out of equipment.
- Previous experience with PLC's, HMI's and Control Systems with the ability to apply as a troubleshooting/diagnostics tool.
- Prior experience with systems such as Allen Bradley, Siemens etc.
EDUCATION
- High school diploma, or equivalent, related program or technical school/military education with a mechanical focus and 3 years industrial experience or 5 years industrial production maintenance and repair experience in a GMP manufacturing environment.
QUALITIES
- Maintain a positive working relationship across all of the LSNE Operations facility.
- Working knowledge of cGMPs, OSHA and industry safety policies and radiation safety techniques. D
- Demonstrated proficiency in computer skills including but not limited to Microsoft Office.
- Experience with computerized maintenance management software (i.e., Blue Mountain)
PHYSICAL REQUIREMENTS & MENTAL DEMANDS
- Ability to lift 50 pounds. Must be able to work/stand on feet all day.
COMMUNICATIONS & CONTACTS
- Interacts with all cross functional departmental staff across all sites.
- Communicates with other departments under limited to no direct supervision and constant communication with department managers and supervisors.
MANAGERIAL & SUPERVISORY RESPONSIBILITIES
TRAVEL < 10% #LI-HA1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
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PCI Pharma Services
Nov 18, 2024