- Leads, schedules, and completes multiple projects of high complexity with multi-disciplinary departments to ensure accurate completion of results.
- Serves as principle/validation liaison for collaborating with clients on agreements/projects and resolution of significant validation, product and regulatory issues
- Coordinates, reviews and prepares customer audit responses and reports.
- Authors, performs reviews and approves production, validation, protocols and reports and/or procedures, and rationales
- Author validation plans; assist with the development of specifications for user requirements, functional requirements, and design requirements, trace matrices, validation summary reports and test protocols for installation, operation, performance of equipment, functional requirements, risk assessments, and IQ/OQ/PQ.
- Review commissioning, qualification and validation related system lifecycle documentation and design specifications, commissioning and qualification protocols).
- Assist with direction on equipment/process change control development (equipment, utilities, facilities, and processes) used to develop and manufacture products in a cGMP environment.
- Identify protocol discrepancies from established product or process standards and provide recommendations for resolving protocol discrepancies.
- Analyze validation test data to resolve whether systems or processes have met validation acceptance criteria or to identify root causes of production problems
- Evaluates new regulations, changes to existing regulations and regulatory trends; performs gap analysis to resolves deficiencies and take appropriate actions.
- Defends policies, procedures, rationales and methods in the area(s) of expertise during regulatory and client audits.
- Additional responsibilities assigned as needed by manager.
- Bachelor's degree in engineering or Biological science related field preferred
- 5 years experience in CQV (Commissioning, qualification and validation)
- Meaningful work experience in the pharmaceutical or a regulated industry, is preferred.
- Ability to work in a fast paced environment with multi-tasks.
- Effective time management and prioritization skills
- High degree of interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle critical matters. Highly effective verbal and written communication skills.
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Engineer III, Validation
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Engineer III, Validation - Plainville, United States - Thermo Fisher Scientific
Description
Job DescriptionPosition summary
Validation engineers lead, inspect, calibrate, test and modify the instrumentation, equipment, mechanics and procedures used in manufacturing. A critical aspect of their job is documenting this process so there is evidence that systems are operating safely and efficiently.
How will you make an impact?
As part of our team, what you do contributes directly to our mission; enabling our customers to make the world healthier, cleaner and safer.
Key Responsibilities:
ACCESSIBILITY/DISABILITY ACCESS
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