Back to Job SearchROLE OVERVIEW
We are currently looking for a Senior Process Validation Lead to join a leading biopharmaceutical company supporting a strategic expansion project within the Bio Drug Substance Validation team. This is an exciting opportunity for a seasoned validation professional to play a key role in the scaling up of biologics manufacturing capabilities, overseeing critical validation activities for a new production facility. The role offers a dynamic environment where your expertise will directly contribute to regulatory submissions and operational excellence.
Based at our client’s site, the role involves close collaboration with cross-functional teams including Manufacturing, QA, Regulatory Affairs, and MSAT, within a dedicated Validation Department. You will be an integral part of the team, responsible for ensuring successful validation outcomes in a GMP-compliant environment, initially focusing on documentation, with potential for on-site activities as the project progresses.
KEY DUTIES AND RESPONSIBILITIES
Your duties as the Senior Process Validation Lead will be varied; however, the key duties and responsibilities are as follows:
• Develop, update, and review Process Validation strategies and supporting documentation for a complex biologics manufacturing expansion.
• Coordinate validation activities across manufacturing, quality, regulatory, and project teams to ensure alignment and timely deliverables.
• Review and prepare validation protocols, reports, and documentation to support regulatory submissions and compliance.
• Consolidate validation data, verify process control demonstrations, and investigate discrepancies or gaps in information from operational systems.
• Act as the SME within validation workstreams, providing expertise and guidance for validation activities.
• Track project timelines, deliverables, risks, and validation KPIs to ensure project milestones are met.
• Participate in risk assessments, ensuring GMP adherence and Data Integrity compliance.
• As the Senior Process Validation Lead, you will work closely with existing specialists, providing direction and ensuring seamless integration of validation activities in a fast-paced environment.
ROLE REQUIREMENTS
To be successful in your application to this exciting role as the Senior Process Validation Lead we are looking to identify the following on your profile and past history:
• A Degree or higher level in a relevant field (e.g., Pharmaceutical Chemistry, Biotechnology, Quality Assurance, or Quality Management).
• Proven hands-on experience in Process Validation within the pharmaceutical or biotech industry, specifically in biologics or Drug Substance environments.
• Ability to independently define validation strategies, author documentation, and compile validation data, demonstrating strong technical proficiency.
• Excellent understanding of GMP requirements, regulatory expectations, and validation principles, including experience supporting large-scale manufacturing projects.
• Fluent French for daily communication, with good written English for documentation purposes.
• Strong autonomy, resourcefulness, and proactive approach to working with multiple stakeholders under demanding project timelines.
WHAT’S IN IT FOR YOU?
Joining our client’s team provides an excellent platform to develop your career supporting high-impact projects within the biopharma sector. You will have the opportunity to work in a collaborative environment with exposure to cutting-edge biologics manufacturing and validation practices, potentially influencing future plant expansions and regulatory submissions. Additionally, this role offers hybrid working arrangements, with up to 40% remote flexibility, in a dynamic and forward-thinking organisation committed to professional growth.
Key Words: Process Validation / Biologics / GMP / Regulatory Compliance / Validation Documentation / Project Management / Stakeholder Coordination / Biopharmaceutical / QA / Regulatory Submissions
"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.
