Pharmalucence formally CIS-US Inc.
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Available Positions
Benefits
Pharmalucence
Careers

Available Positions
Pharmalucence is an Equal Opportunity Employer
Process Manufacturing Engineer III

Summary

Oversees, coordinates and/or implements process equipment/utilities maintenance and maintenance according to current Good Manufacturing Practices (cGMPs) and following Standard Operating Procedures (SOPs)
 
Responsibilities and Tasks

  • Support/ Oversee 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
  • Responsible for all process equipment associated documentation/operation/maintenance
  • Support PM re-qualification of process equipment, testing & certifications of manufacturing process 
  • Support area manufacturing and new product/process transfer activities
  • Execute and follow up on equipment/utility related CAPAs, Deviations, and Investigations
  • Review process utilities and equipment logs
  • Oversee loading / lyophylization cycle and coordination of equipment
  • Troubleshoot and remediate exceptions found during FAT/SAT/IQ/OQ/PQ
  • Provide peer review for engineering documentation
  • Own and 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

Knowledge Skills and Abilities

  • Ability to schedule and oversee cGMP validation compliance efforts
  • Ability to operate and maintain all process equipment (Sterilizers, Depyrogenation Ovens, Lyophilers, Incubators, CTU’s)
  • Familiarity with FDA cGMP, SOPs and ISO standards
  • Knowledge of pharmaceutical manufacturing equipment and utilities
  • Familiarity/Knowledge of aseptic techniques
  • Excellent organizational skills
  • Ability to work independently

Education and Experience

  • Bachelor’s in Science, Engineering or related field preferred or equivalent experience
  • Minimum 3-5 years related experience preferred

 

 

Disclaimer
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 Industries, Inc. (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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29 Dunham Road, Billerica, MA 01821 | Telephone: 781-275-7120    © Pharmalucence Inc. All rights reserved.
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