Back to Job SearchROLE OVERVIEW
An exciting opportunity for a CSV Specialist to join a leading pharmaceutical company’s Biological Drug Substance Business Unit, working on a pivotal CAPEX project aimed at doubling upstream capacity. Our client is seeking a proven professional to support qualification and validation activities related to new equipment, systems, and functionalities, ensuring compliance with GMP standards throughout this major project. This role offers a unique chance to contribute to high-impact infrastructure enhancements in a collaborative, fast-paced environment.
Based onsite with flexible remote options, you will be integral to a dynamic project team supporting a critical phase of plant expansion. Join now to be part of a transformative initiative that will influence research activities, existing facilities, and new equipment validations through 2027 and beyond.
KEY DUTIES AND RESPONSIBILITIES
Your duties as the CSV Specialist will be varied however the key duties and responsibilities are as follows:
- Support and execute CSV activities related to new equipment, systems, and process upgrades within the CAPEX project.
- Qualification and validation of PCS / automation systems, new recipes, and functionalities, including safety systems.
- Adapt existing systems to integrate with new equipment and processes.
- Collaborate closely with Automation, IT, Validation, and external suppliers to structure and ensure the quality of CSV project deliverables.
- Provide active support to the Automation team to maintain project timelines and quality standards.
- As the CSV Specialist, you will ensure all validation documentation and processes align with GMP requirements and company standards.
ROLE REQUIREMENTS
To be successful in your application to this exciting role as the CSV Specialist, we are looking to identify the following on your profile and past history:
- A Degree or higher level in Engineering or a relevant field .
- Proven experience in CSV within a pharmaceutical/GMP environment, with a strong understanding of qualification & validation strategies and GMP requirements.
- Experience working on complex CAPEX projects in biotech or drug substance settings, with excellent cross-functional collaboration skills.
- Fluent in French (working language) with a good command of English to liaise with non-French speaking partners and contractors.
Key Words: CSV / Validation / Pharmaceutical / GMP / CAPEX / Automation / PCS7 / Biotechnology / System Safety / Qualification / Validation Strategy / Cross-functional / Project Management / Validation Documentation
"Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career".
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
