Job description

Senior Validation Engineer
Norcross, GA
Medical Device

up to $130,000 DOE plus bonus

Qualifications:

• Bachelor's degree in Biomedical Engineering, Chemical Engineering or related science/engineering discipline
• With 5+ years validation experience
• OR Master's with 3+ years validation experience, Doctorate with 1+ years validation experience
• Experience in the biotechnology industry or another similarly regulated industry (i.e. medical device, pharmaceutical)
• Validation experience within blood banking and/or transfusion medicine and immunodiagnostics, preferred
• Six Sigma Green Belt Certification, preferred

Responsibilities:

• Supporting the establishment, reporting, and achievement of performance metrics and objectives representative of an industry-leading Validation
• Training and mentoring contractors and other staff within your area(s) of expertise, including peer review and/or approval of related documents
• Developing and executing engineering and validation strategies, plans, and protocols for assigned regulatory compliance, change control, and design control projects, including Operations continuous improvements and technical transfers
• Writing and processing documents through company systems
• Remaining up-to-date and ensuring compliance with current industry trends as well as Quality Systems, ISO13485, cGMP and other relevant regulatory protocols
• Providing support for internal and external audits and Quality System investigations
• Creating and revising SOPs supporting Validation Program functions and activities

Job Type: Full-time

Salary: $100,000.00 - $130,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• Day shift
• Monday to Friday
• No weekends

Ability to commute/relocate:

• Norcross, GA 30093: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Preferred)

Experience:

• Validation: 5 years (Preferred)
• ISO 13485: 5 years (Preferred)
• FDA regulations: 5 years (Preferred)

License/Certification:

• Six Sigma Green Belt (Preferred)

Work Location: One location

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.