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Division
Piramal Pharma Solutions
Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.
This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.
Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.
For more details, please visit : www.piramalpharmasolutions.com
Job Title
EXPANSION FEQ Technician
Job Description
Business: Pharma Solutions
Department: Facilities & Equipment
Location: Lexington
Job Overview
Reporting to the Maintenance Supervisor, the role of the FEQ Technician is to properly and efficiently calibrate, maintain, troubleshoot and repair process, facility, and laboratory equipment and instrumentation. Skills in electrical and mechanical are essential to performing this job.
Shift
Nights
Reporting Structure
This position reports to the Maintenance Supervisor.
Key Responsibilities:
- Responsible for performing routine and non-routine calibration of critical, non-critical, and safety related instruments used to support cGMP process manufacturing, packaging, facility and other material testing processes.
- Possess instrumentation, controls, and electrical skills in order to identify equipment issues and make the necessary repairs.
- Works interdepartmentally to coordinate routine and non-routine activities, work closely with Operations personnel to obtain information needed to assess equipment problems in a courteous / professional demeanor, as well as coordinate and oversee the work of vendor technical personnel.
- Establish and maintain any necessary procedures and processes required to perform routine calibration and maintenance of equipment and systems throughout the plant.
- Perform all activities in compliance with company, cGMP, and safety policies, procedures, and practices.
- Foster and promote a customer service culture within the department and company.
- Operate PCs and various interface hardware and software to support automation platforms/components such as PLCs and HMIs.
- Work in a cGMP facility utilizing Good Documentation Practice while completing Work Orders, Log Books, CAPAs, Change Controls, Investigations, & all other regulated forms.
- Follows & enforces all SOPS and regulations in the Maintenance & Engineering department
- Exercise technical, mechanical and control system aptitude / skills in order to accurately identify root causes for machine failures or break downs and repair accordingly.
- Uses reliability technologies to identify equipment that is not working within specifications
- Performs, evaluates, and submits revisions to PMs to improve equipment reliability
- Identifies, sources, and orders wear and spare parts for inventory
- Assists in the set-up, change over, and operation of various pharmaceutical manufacturing equipment
- Read and understand technical information provided in equipment manuals and any associated electrical or mechanical drawings.
- Works safely with electricity, steam, compressed gasses, chemicals and mechanical moving parts
- Verifies dimensions and tolerances, using precision-measuring instruments
- Read and understand PLC (programmable logic controller) control logic, as well as other configurable controllers such as VFDs, relay logic, etc.
- Troubleshoots and replaces bearings, gears, pulleys, shafts. Changes oil and filters. Rebuilds pumps and other mechanical equipment.
- Ability to work extended shifts, weekends, holidays, and be on-call as needed to provide maintenance support.
- Must be physically capable of climbing ladders, working with minute hardware, working in a lying position, working with arms extended overhead.
- Must be physically capable of using a respirator and other personal protection devices/equipment.
- Performs other duties as assigned
Qualifications:
- Required: High school diploma or equivalent.
- Preferred: Technical Certification
- Highly desirable: Associate's degree in Engineering or Electrical Technology or related discipline.
- Required: 5+ years of maintenance or technical/mechanical trade experience or combination of experience and education
- Preferred: Hands-on calibration, instrumentation and electronic equipment/controls maintenance experience.
- Highly desirable: Pharmaceutical or related industry electromechanical experience.