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Pharmalucence
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Pharmalucence is an Equal Opportunity Employer
Sr. Validation Engineer

Summary

The Senior Validation Engineer III provides leadership, with hands-on involvement, to validation team members in the strategic planning and qualification of new and existing process equipment/utility systems.

Responsibilities and Tasks

  • Works with Cross-functional teams in the detailed design, specification, procurement, construction, and commissioning of process equipment for cGMP production facilities.
  • Independently initiates and drives the completion/closure of quality system events such as Investigations, Deviations, CAPAs, and Change Controls.
  • Serves as subject matter expert in supporting the development, execution, and data analysis of site-wide process equipment validation deliverables.
  • Serves as subject matter expert in supporting the development and implementation of class-validation strategies for process equipment.
  • Supports the development of solutions to equipment malfunction and manufacturing process inefficiencies of varying complexity.
  • Demonstrates and maintains thorough knowledge and understanding of FDA requirements and expectations relating to steam sterilization, depyrogenation, Lyophilization, and clean utility systems.
  • Demonstrates Risk Assessment, Protocols, Reports, Process Specifications, and User Requirements.
  • Provide Review and Engineering Approval of deviations and investigations with respect to validated equipment and validated processes.
  • Represents the Validation group in project teams, audits, and inspections.
  • Supports and/or leads the development of long-range validation program development goals and objectives.
  • Provides technical assistance and/or directly supports Development, Production, and QC groups on procurement and qualification of manufacturing equipment for new cGMP processes.
  • Manages all functions of the process equipment Re-Qualification program, coordinating validation team resources, maintaining test equipment/materials inventory, and coordinating equipment availability with manufacturing team management.
  • Communicates project requirements to vendors to obtain proposals for equipment and piping changes.
  • Troubleshoots and remediates deviations encountered during FAT/SAT/ IQ/OQ/PQ.

Knowledge, Skills, and Abilities

  • Direct experience in GMP facility construction, process equipment installation, commissioning, and qualification.
  • Direct experience in commissioning and qualification of washers, steam-sterilizers, lyophilizers, depyrogenation ovens, automated filling lines, and clean process utilities.
  • Direct experience working in an aseptic fill and finish manufacturing environment.
  • Strong knowledge of industry standards for sterility assurance in an aseptic manufacturing environment.
  • Strong ability to work with a team and direct the work of other team members.
  • Working knowledge of domestic and international cGMP regulations.
  • Strong technical writing skills with demonstrated ability to independently develop SOPs, protocols, production batch records, etc.
  • Proficiency with Microsoft Office software products.
  • Proficiency with configuration and operation of the Kaye Validator 2000
  • Demonstrated proficiency with instrumentation and controls configuration, operation, and troubleshooting

Education and Experience

  • B.S. in a related science field required; Chemical or Mechanical Engineering preferred
  • Minimum 7-9 years of experience in a cGMP manufacturing environment

 

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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