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Quality Assurance Validation Engineer
2 months ago
Valspec, a prominent global provider of system validation and lifecycle services, is dedicated to delivering commissioning and qualification of computerized systems for clients within the Life Sciences sector. Our mission, established in 1999, is to offer a comprehensive range of services that assist our clients in achieving their capital project and lifecycle maintenance objectives.
The projects we undertake are vital to the industry and the individuals who depend on our products. Many of these initiatives facilitate the availability of life-saving medications; others enhance production efficiency to meet demand at reduced costs, paving the way for the discovery of innovative therapies.
Position: Validation Engineer
Location: Texas
We are in search of a versatile and resourceful Validation Engineer to provide computer system validation support for a leading contract development and manufacturing organization (CDMO) that specializes in biologics and advanced therapies. In this role, you will be responsible for the validation strategy and Software Development Life Cycle (SDLC) documentation for systems including Emerson DeltaV, Siemens Desigo, Lab, and Building Automation Systems within the life sciences manufacturing environment.
Key Responsibilities
- Formulate and implement validation strategies and plans for Emerson DeltaV, Siemens Desigo, Lab, and Building Automation Systems, ensuring compliance with regulatory standards, industry best practices, and company protocols.
- Lead the development, review, and approval of validation documentation, which includes validation plans, protocols, reports, risk assessments, and traceability matrices.
- Work collaboratively with cross-functional teams to ensure thorough requirements gathering and mapping for validation tasks.
- Oversee Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and commissioning activities for various systems.
- Conduct risk assessments and impact analyses to identify potential challenges and devise mitigation strategies.
- Ensure adherence to data integrity standards and implement measures to uphold data integrity throughout the validation lifecycle.
- Provide support and guidance to project teams regarding Computer Systems Validation (CSV) principles and best practices.
- Coordinate with external vendors and contractors to manage validation activities and ensure compliance with project timelines.
Qualifications and Skills
- Bachelor's degree in Engineering, Computer Science, or a related discipline.
- A minimum of 5 years of experience in CSV and validation within the pharmaceutical or biopharmaceutical sectors.
- Strong proficiency in validating computer systems, with specific experience in Emerson DeltaV, Siemens Desigo, Lab, and Building Automation Systems.
- Comprehensive understanding of regulatory requirements (FDA, EMA, etc.) and industry standards (GAMP, 21 CFR Part 11) pertinent to CSV and validation.
- Demonstrated experience in developing and executing validation strategies, plans, protocols, and reports.
- Solid grasp of SDLC and familiarity with Agile methodologies.
- Extensive experience with data integrity principles and their application in CSV activities.
- Exceptional problem-solving abilities and the capacity to analyze complex systems and processes.
- Proven ability to collaborate effectively with cross-functional teams.
- Proactive approach with meticulous attention to detail and the ability to prioritize tasks efficiently.
- Experience in a regulated GxP environment is essential.
- Prior experience in a leadership or mentoring capacity is highly advantageous.
Joining Valspec as a Validation Engineer will provide you with the opportunity to significantly influence the validation and CSV processes for advanced life sciences manufacturing systems. We are committed to fostering a professional environment free from discrimination or harassment and take pride in being a Drug-Free Workplace.
Benefits: Valspec offers a supportive culture, an excellent work environment, and competitive benefits, including premium medical coverage, 401K matching, profit sharing, tuition reimbursement, and other unique incentives.
