Lupin Pharmaceuticals (Company Headquarters)

Sr. Quality Assurance Validation Engineer

US-NJ
2 months ago
Job ID
2017-2057
# of Openings
1
Category
Quality Assurance

Overview

The Sr. Validation Scientist/Engineer is responsible for carrying out validation activities as they relate to manufacturing and packaging processes, process hold times, cleaning processes, and facilities/utilities/equipment within the Lupin Somerset site. This position assures that all validation activities are executed with the highest quality and meet all applicable SOP’s and regulatory standards. This position will also be responsible for leading Validation projects.

Responsibilities

  • Lead Validation projects including the oversight of third party contract assignments
  • Demonstrate expertise in Equipment Qualification
  • Write or review validation/qualification protocols and respective reports
  • Maintain validation packages in support of commercial product in compliance with current regulations/standards
  • Execute Validation/Qualification plans to support product launches, process improvements, and continued commercial production
  • Initiate any applicable change controls with respect to validation activities, track and follow-up with the required departments to close the change controls
  • Write or review IQ/OQ/PQ protocols of process equipment and facility modifications and suggest any required changes.
  • Write or review the protocol reports and ensure that qualifications are performed properly
  • Oversee the environmental sampling of air from process rooms on quarterly basis and send to outside Microlab for testing; receive, review, and analyze the results for any trends
  • Create any new SOP’s and revise the existing SOP’s applicable to validation; train and mentor department personnel

Qualifications

  • BS/MS in Engineering discipline or Life Sciences
  • 8+ years experience in equipment qualification in the pharmaceutical industry
  • Excellent knowledge of cGMP in the pharmaceutical/biotechnology industry
  • Working knoweldge 21CFR part 11
  • Excellent computer skills; Microsoft Excel, Word, and Powerpoint
  • Strong problem-solving skills, strong verbal and written communication skills, and the ability to work independently.
  • Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required

Physical Requirements

The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 35 pounds occasionally. Generally work is performed in manufacturing and laboratory environments.

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