Job description

Validation Engineer

East Greenbush, NY

Duration : 1-2 years

Working hours are Mon – Fri and two separate shifts (0700 to 1500 & 1500 to 2400). Please identify which shift or both shifts the candidate is willing to support. There will only be a one-week vacation approved with 2 months’ notice.

• A solid understanding of FDA Validation guidelines GMP and regulatory experience with expertise in process validations

• Experience in writing and executing validation protocols (i.e. DQ, IQ, OQ, PQ) Knowledge of specific manufacturing equipment

• Complete appropriate cGMP documentation throughout validation life-cycle

• Executes qualification and validation in compliance to regulatory requirements by/with/as carry out qualification and validation according to the Validation Program. Use test equipment, instruments and methods to produce data for validation.

• Perform data analysis using statistical methods as appropriate to produce conclusions and recommendations for relevant work activities

• Document root cause and corrective/preventive actions of gap found during validation activities Work under minimal supervision.

• Relies on experience and judgement to plan and accomplish assigned goals.

• May periodically assist in orienting, training , assigning and checking the work of lower level employees.

Judgement is required in resolving complex problems based on experience

• Supports Project Teams in: GMP Impact Assessments, Instrument Criticality Lists, Critical Components Lists, Requirements Traceability matrices, Design Qualification, Vendor documentation checklists, final handover of documents to Operations Assisting in troubleshooting of process issues, process characterization and root cause investigations Involved in resolving deviations / non-conformances observed during execution of qualification and validation activities.

• Ability to prepare / issue change controls, CAPAs, and investigations

• Ability to maintain gowning requirements as needed to access controlled areas Demonstrated deep technical skills in aseptic manufacturing/process

Equipment:

Filling Line is based on modules and qualification includes and is not limited to:

• Debagger Modules

• E-Beam Module

• Rapid Decontamination Module (SARA) (Grade A)

• Delid/Deliner Module

• Filling Module

• Capper Module

• Grade A Isolators

• Inspection Machine

• Auto-Injector Assembly

• Packaging Line

• Formulation Suite (scales, CTUs, filter integrity tester, incubators, SUMs)

• Formulation Suite 1 contains Single Use Mixers, Weigh Scales and Filter Integrity Testers.

• Documents, execution, reports that may be included but not limited to

Job Types: Full-time, Contract

Salary: $67,633.76 - $130,240.88 per year

Experience level:

• 1 year
• 2 years
• 3 years
• 4 years
• Under 1 year

Schedule:

• 8 hour shift

Work Location: On the road

seankuhnke.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, seankuhnke.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, seankuhnke.com is the ideal place to find your next job.