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Validation Engineer - Indianapolis, United States - Katalyst HealthCares & Life Sciences
Description
Responsibilities:
Determine project scope and strategy with client groups and other stakeholders to execute small and large capital projects in a cGMP environment.
Participate in the development of the following Validation efforts: Validation Planning, Protocol Generation, Protocol Execution, Familiar with GAMP/GMP process, and not limited to FATs/SATs, Product validation risk assessments, IOQ's, PQ's etc.
Directs project validation work to ensure the manufacture of high-quality product and to facilitate compliance with regulatory requirements.
Liaise with internal engineering project co-ordination team, consultants, subcontractors, supervisors and the general workforce involved in the project to ensure full compliance with solution requirements.
Leading and supporting SATs.
Work with cross functional teams during the commissioning and validation phases of a project, ensuring clear communication and hand-off of information.
Supporting and representing the technical quality team in meetings, visits, troubleshooting exercises, and audits
Help determine, draft, and author project cGMP documentation such as Validation Master Plans, Specific Validation Project Plans, Schedules, IQ/OQ/PQ Protocols, Final Reports, Deviations, and Investigation support.
Assist with the development of project schedules by studying project plans, system boundaries, and validation package deliverables; calculating time requirements; sequencing validation elements.
Prepare validation reports by collecting, analyzing, and summarizing information during execution.
Help oversee vendor activities to include coordination and communication to ensure project efforts progress while maintaining safety.
Performs duties in compliance with environmental, health and safety related rules, policies or governmental regulations.
Requirements:
Bachelor's degree in engineering.
8 to 15 years of experience in the in the Engineering/Manufacturing/ Scientific field with Commissioning, Qualification and Validation of Equipment (Extruders, Molds & Molding equipment, automation for manufacturing), Utilities and/or Facilities in a cGMP environment
Works without supervision and is Quality driven
GMP/cGMP change control process experience.
Validation/qualification process knowledge.
Creative thinking and problem-solving skills
Attention to detail.
Proven track record of being self-motivated and capable of working in diverse team situations with Company clients and maintaining a positive attitude towards project challenges.
Experience with supporting Supplier Validations, Supplier Changes, Supplier Management and Component Qualification; preferably experience with Injection Moulding, Metal forming, extrusion, automation for manufacturing.
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