Validation Engineer

Location: Buena, NJ

Job Summary

The Validation Engineer will be responsible for preparation, execution, and reporting of validation  and qualification (IQ/OQ/PQ) deliverables for Semi Solid and Liquid Dosage Pharmaceutical manufacturing including Process, Packaging and Cleaning validation development and monitoring in a cGMP facility. Experience in concepts of qualification of equipment and instrumentation as well as validation of processes.

Essential Responsibilities

  •  Participate and support the process validation, equipment qualification, and cleaning validation programs for both sterile and non-sterile processes.
  • Develop and execute validation and qualification protocols and reports for the Facility, Manufacturing Processes, Manufacturing Equipment, Packaging Equipment, Packaging Processes, Utilities, and Cleaning Processes for all equipment and products.
  • Develop and maintain validation and qualification system level documents including Validation Master Plans.
  • Working with Quality Assurance, maintain and administer the change control program for qualification of the equipment and facility.
  • Assists in the development of User Requirement Specifications and other relevant facility start-up documentation.
  • Provide technical Support to Formulation R&D for scale up and production batches.
  • Responsible for Quality reviews and appropriate approval of the documents in compliance with regulatory requirements.
  • Support Formulation R&D and technical services teams in executing GMP batches for manufacturing purposes.

Qualifications

  • Master Degree in Engineering or similar degree with a minimum of 2 years of experience in Pharmaceutical/Medical Device Industry or Bachelor’s degree with a minimum of 5 years of experience in Pharmaceutical/Medical Device Industry.
  • Experience in  a sterile manufacturing and packaging process validation.
  • Experience in Equipment and Facility Qualification in sterile GMP environment; start-up experience strongly preferred.
  • Understanding of cGMP’s, FDA, Safety and pharmaceutical industry guidelines.
  • Strong technical writing skills.
  • Willingness to work as a team and under time/ work pressure.
  • Should have excellent verbal communication abilities.
  • Good interpersonal, organizational and communication skills (both oral and written) and demonstrated skills in team matrix working. Proven ability to deliver technical reports and presentations.
  • Must know MS Office, WORD, and EXCEL, Auto CAD is a plus.
  • Demonstrated understanding reviewing/writing technical documents, risk assessment reports, validation documents, protocols and final reports.

This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.

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