Job Summary
Coordinate and/or implement process and utility equipment maintenance and troubleshoot as accordance to current Good Manufacturing Practices (cGMPs) and following Standard Operating Procedures (SOPs).
Area Of Responsibility
- Subject Matter Expert for Inspection, Labeling and Packaging Equipment
- Experience using SAP, Tracelink, Optel, Bartender and/or related software/systems
- Responsible for maintenance and operation of process equipment as well as associated documentation
- Support execution of preventative maintenance of pharmaceutical process equipment and utilities
- Ensure that the equipment is prepared to support the production schedule and is in proper condition/calibration
- Provide 24/7 operational coverage for manufacturing equipment and utilities
- Support production personnel on equipment and utility operation
- Support re-qualification of process equipment, testing & certifications of manufacturing process
- Support area manufacturing and new product/process transfer activities
- Follow up on equipment/utility related CAPAs, Deviations, and Investigations
- Review process utilities and equipment logs
- Support loading / Lyophilizer cycle and coordination of equipment
- Troubleshoot and remediate exceptions found during production
- Ensure timely closure of equipment/utility related CAPAs and/or Change Controls
- Support Validation of equipment/utilities/process transfers and re-qualifications
- Support URS/FS/DS engineering documents of process related systems
- Designs, develops, under supervision all aspects of electrical control systems, equipment, (including HMI and PLC code), based on approved PID’s
- Will be responsible for the installation and technical support of PLC based hardware and software
- Other duties as assigned
Work Conditions:
- Office
- Lab
- Manufacturing area/clean room area/utility area.
- Maintenance Shop
- Exposure to noise, hot and cold, outside elements, some radiation
Physical Requirements:
- Stand, sit, walk, use hands and fingers to handle or feel, reach with hands and arms
- Climb or balance, stoop, kneel, crouch or crawl, talk, hear, taste, smell
- Close vision; ability to adjust focus
- Operate computer/office machines, autoclave, Depyrogenation oven, vial filler, freeze dryer, steam generators, power tools
- Wear proper gowning and safety equipment as needed
- Lift up to 50 lbs.
Travel Estimate
Up to 0%
Education and Job Qualification
- Bachelor’s in Engineering Electrical/Electronic field preferred or equivalent experience
Experience
- Minimum 2+ years proven PLC/HMI troubleshoot experience
- Ability towards process coding preferred
- Ability to oversee cGMP validation compliance efforts
- Familiarity with FDA cGMP, SOPs and ISO standards
- Knowledge of Aseptic pharmaceutical manufacturing equipment and utilities
- Familiarity/Knowledge of aseptic filling Isolators, Lyophilization, CIP and SIP
- Excellent organizational skills
- Knowledge of project management for small to medium size projects.
- Knowledge of operating and maintaining secondary packaging machine (Auto Capper, Auto labeler, Auto Cartonner)
The presently-anticipated base compensation pay range for this position is $98,000 to $119,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.
Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.
The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
Notice to Agency and Search Firm Representatives:
Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Taro employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Taro. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.