Validation Engineer - Kentucky

Responsibilities

• Develop, execute, and oversee cleaning validation strategies and protocols for solid dose manufacturing equipment and processes.
• Collaborate with cross-functional teams to establish cleaning validation requirements, ensuring alignment with regulatory standards and industry best practices.
• Perform risk assessments and gap analyses related to cleaning processes, proposing and implementing corrective actions as needed.
• Generate and maintain cleaning validation documentation, including protocols, reports, and standard operating procedures (SOPs).
• Conduct equipment qualification activities in coordination with the validation team.
• Coordinate and execute cleaning validation studies, ensuring thoroughness and accuracy in data collection and analysis.
• Investigate and resolve deviations related to cleaning processes, collaborating with Quality Assurance and Manufacturing teams.
• Stay abreast of industry trends, regulatory requirements, and technological advancements in cleaning validation, providing recommendations for continuous improvement.
• Participate in regulatory inspections and audits, providing support and documentation as required.

Requirements

• Bachelor's or higher degree in a relevant scientific or engineering discipline.
• Proven experience in cleaning validation within the solid dose industry.
• Knowledge of regulatory guidelines and requirements related to cleaning validation (FDA, EMA, ICH, etc.).
• Strong understanding of biopharmaceutical manufacturing processes and equipment.
• Familiarity with risk-based approaches to cleaning validation.
• Excellent documentation and record-keeping skills.
• Detail-oriented with strong analytical and problem-solving abilities.
• Effective communication skills and the ability to collaborate with cross-functional teams.
• Certification in validation or related areas.
• Experience with solid dose and associated cleaning validation.
• Join Valspec and contribute to the advancement of cutting-edge life sciences through your expertise in cleaning validation. We offer a collaborative and innovative work environment dedicated to fostering professional growth and development. Apply now to be a part of our dynamic team!
• Why Join Valspec?
• Premium medical coverage
• 401(k) with company match
• Tuition reimbursement
• Unique performance incentives
• And more - all designed to support your growth, well-being, and future.
• Join a team where your contributions matter, your development is prioritized, and your success is shared.
• When receiving e-mails from a Proconex or Valspec recruiter, you will only receive e-mails from addresses ending in @proconexdirect.com, @proconex.net or @valspec.net. Any other domains are impersonations and should be ignored.
• Candidates must be legally eligible to work in the United States without company sponsorship. Also, we are not interested in working on a corp-to-corp basis with other companies at this time.
• Any third-party unsolicited resume submission(s) will immediately become the property of Valspec. Valspec will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established.

Benefits

Additional Information

Valspec-a global provider of system validation and lifecycle services-provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec's mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals. Valspec's projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies. Validation Engineer Job Type: [Full-time/Contract] Valspec is seeking a highly motivated and detail-oriented Cleaning Validation Engineer to join our dynamic team. The successful candidate will play a crucial role in ensuring the cleanliness and compliance of our solid dose manufacturing processes through effective cleaning validation protocols.

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