ELIQUENT Life Sciences is the leading global consulting firm providing solutions to life science companies researching, developing, and manufacturing innovative products to serve patients and respond to public health challenges around the world. ELIQUENT is committed to serving clients’ needs with extensive expertise, unwavering integrity, and strategic insight in a manner that supports availability of safe, effective, and high-quality drugs, biologics, and medical devices. For more information, please visit our website at eliquent.com.
We are looking for a detail-oriented and experienced CSV Engineer to join our team. The CSV Engineer will be responsible for ensuring that computer systems and software used in regulated environments meet compliance requirements and operate according to user specifications. The ideal candidate will have a strong background in CSV, an understanding of industry regulations, and the ability to manage validation projects from start to finish.
Key Responsibilities:
- Write and execute validation documentation including User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), and Requirement Traceability Matrices (RTM).
- Review and approve vendor and third-party custom software documentation to ensure it meets internal validation requirements.
- Ensure compliance with GAMP 5 guidelines for custom designed software system including complete functional testing and source code review.
- Co-ordinate with cross-functional teams (e.g., IT, quality assurance, engineering) to ensure proper validation processes are followed.
- Provide on-going support for system changes, including software design change and re-configuration.
- Perform data integrity assessments and ensure proper data handling practices are followed for bespoke system.
- Communicate project status, issues, and risks to clients and internal teams.
- Provide technical expertise and guidance to clients and project teams throughout the validation process.
- Stay updated on industry trends, regulatory changes, and technological advancements to ensure compliance and improve validation practices.
- Work closely with clients to understand their needs and requirements, providing expert advice and solutions.
- Collaborate with cross-functional teams, including IT, Quality Assurance, and regulatory compliance, to achieve project goals.
Requirements
- Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a related field. Advanced degrees are a plus.
- Minimum of 7-10 years of experience in Computer Systems Validation within the pharmaceutical, biotechnology, or medical device industries.
- Familiar with GAMP 5 methodology and PAT technology, specifically in C&Q of custom designed manufacturing skids. Prior experience in IVT, chromatography, TFF, LNP skids is a plus.
- Ability to review technical documentation from DCS/Historian/Batch software vendor, draft configuration specification and test protocol to verify custom software design and configuration settings.
- Proven experience with validation of computerized systems, software applications, and electronic records.
- In-depth knowledge of CSV principles, regulatory requirements, and industry standards.
- Proficiency in writing and reviewing validation documentation, including validation plans, protocols, and reports.
- Strong analytical and problem-solving skills with a keen attention to detail.
- Excellent communication and interpersonal skills, with the ability to work effectively with clients and team members.
We not be able to provide sponsorship for this role
Benefits
What We Offer:
- Competitive Compensation: Attractive salary and comprehensive benefits package for full-time and part-time employees, including health, dental, vision, and life insurance, a 401(k) plan with employer match, a generous paid time off policy, and additional perks. Compensation is commensurate with professional experience.
- Career Development: Opportunities for professional growth and advancement within a supportive and innovative environment.
- Work-Life Balance: Flexible work arrangements and a commitment to maintaining a healthy work-life balance.
Eliquent Life Sciences is proud to be an Equal Opportunity Employer, committed to employee diversity.
