Validation Engineer
Validation Engineer
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1 Vacancy
Job Description
Job Summary
To support our extraordinary teams who build great products and contribute to our growth were looking to add a Validation Engineer located in Buffalo IL
Reporting to the Quality Manager the Validation Engineer will support our extraordinary teams who build great products and contribute to our growth. Responsible for process validations to ensure that the equipment used for medical device manufacturing process are appropriately developed qualified to meet Flexs internal policies procedures and regulatory requirements.
What a typical day looks like:
- Provide validation oversight on process validation and qualification activities to ensure compliance and recommend appropriate corrective actions as needed.
- Assure validation policies and procedures are implemented and followed for medical device manufacturing.
- Determine and establish requirements for qualification activities and lead all assigned qualification activities to completion.
- Suggests debates alternative methods and procedures in solving problems to meet business needs.
- Make independent decisions related to qualification activities.
- Author / execute validation plans protocols (IQ OQ TMV and PQ protocol) and other validation deliverables to support equipment qualifications and requalification activities.
- Interface with customers on technical/quality issues and improvement initiatives.
- Responsible for managing regulatory/compliance agency/customer audits by acting as an SME for the respective area / business process.
- Reviews technical problems and procedures; recommends solutions to improve and streamline the existing quality system processes.
- Implement practices around validation controls for all manufacturing areas in line with applicable policies and procedures.
- Executes manages validation and change control activities by authoring reviewing and approving validation deliverables including but not limited to validation plans requirement test plans/protocols/results risk assessments traceability matrices and summary reports.
- Monitor validation deliverables and activities for assigned area to ensure that regulations protocols procedures and methodologies are followed and that appropriate and complete documentation is captured and reported to support validation activities.
- Additionally required to support software or facilities validations as deemed necessary by business.
The experience were looking to add to our team:
- Bachelors (in engineering sciences or related field)
- 3 years of validation experience.
- Prior process validation experience working in medical device pharmaceutical or biotechnology industry with understanding of CFR Part 820 Part 11 ISO 13485 Annex 11 ISO9001 GAMP standards.
- Experience in generating review and approval of validation deliverables statistical analysis risk management incident and change management.
- Experience working in 24/7 operations environment strongly preferred.
What youll receive for the great work you provide:
- Full range of medical dental and vision plans
- Life Insurance
- Shortterm and Longterm Disability
- Matching 401(k) Contributions
- Vacation and Paid Sick Time
- Tuition Reimbursement
Job Category
Design Process & Technology EngineeringIs Sponsorship Available
NoFlex is an Equal Opportunity Employer and employment selection decisions are based on merit qualifications and abilities. We celebrate diversity and do not discriminate based on: age race religion color sex national origin marital status sexual orientation gender identity veteran status disability pregnancy status or any other status protected by law. Were happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email and well discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex you must complete the application process first).Employment Type
Full-Time
