Job Description
Our client, a global healthcare leader with one of the most exciting product pipelines in the industry today now seek a Lead Validation Expert for their biopharmaceutical manufacturing centre of excellence facility. This is a permanent role, based in the greater Basel area (Switzerland / France).
This role will help deliver clinical and commercial supply of recombinant therapeutic proteins manufactured through mammalian cell culture at high quality and competitive cost in their GMP facility. This position has become available due to a major capacity expansion project, focused on the launch of innovative biomedicines.
The Lead Process Validation Expert will define and implement process validation activities linked to
biologics drug substance manufacturing at the site. This includes process validation studies (e.g., validation of process unit operations, holding times, lifecycle studies) and also related systems (e.g., cleaning, site risk management).
The successful candidate will lead support definition of study strategy, planning, and activity coordination, writing and approving documents related to these activities, and communicating progress to site and network management.
Additionally, this hire will be required to work in close collaboration with Process Development, Engineering, Production, Supply Chain, Quality, Regulatory departments, and with other manufacturing sites within the company network, to ensure quality, on-time supply of our products to patients.
Responsibilities for Senior Validation Scientist:
Lead creation and maintenance of the VMP for process and/or site manufacturing systems.
Lead process validation with internal and external process experts, with QA and regulatory prerequisites.
Set local procedures, templates, and evaluations/risk assessments for validation processes, documentation and validation master plans.
Provide guidance to the manufacturing site on the impact of component criticality assessments.
Lead the strategy and risk assessments for OPV, for cleaning processes validation and extractables and leachables studies.
Execute and manage the validation plan according to priorities defined in the plan.
Lead troubleshooting of complex validation relevant issues during manufacturing operations.
Lead investigation teams, deviation management and Change Control management.
Ensure appropriate stakeholder engagement and support, and clearly communicate on progress and issues.
Support validation strategy alignment team including partners from different manufacturing sites (internal/external) and global functions.
Write, review and/or approve CMC sections for regulatory filing documents and responses to questions from Regulatory Agencies.
Represent the Process Validation team during regulatory and routine compliance audits/inspections.
Requirements for Lead Validation Scientist, Biologics:
Degree in life sciences, engineering or biotechnology. Master?s degree preferred.
5+ years professional experience in process validation in GMP biopharma facility.
Experience in executing process validation.
Expert in reviewing and writing technical reports.
Proven project management experience in a cross-functional environment.
Thorough understanding of biopharmaceutical manufacturing processes and related process equipment
Strong working knowledge of quality systems and regulatory requirements with relevant authorities
Fundamental understanding of standard pharmaceutical analytical testing.
For details, please contact Larry on +353-1-2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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