Lead Validation Engineer

Catalyst

Lead Validation Engineer


  Bern, Bern
Posted
1 month ago
Duration
Permanent/Fixed Term
Salary
Competitive
Sector
Engineering

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In this role, you will be in charge for Validation activities for (new) biopharmaceutical processes in the Late-Stage Development department. The Lead Validation Engineer is primary responsible that validation studies are carried out conform global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities.

Key Responsibilities:

  • Define strategy, plan, coordinate and complete all phases for supporting validation activities such as cleaning validation, sterilization, clean rooms performance qualification, hold time validation or mixing validation
  • Define strategy, plan and coordinate of aseptic process simulation (APS)
  • Support execution of Lifecycle Process validation activities such as process performance qualification (PPQ) and continued process validation (CPV)
  • Authoring, review and approve validation plans, protocols, reports
  • Bridging with multi-functional teams handling and ensuring equipment and process readiness for production
  • Operational handling of Change Controls, CAPAs and Non-Conformances related to process validation and supporting validation activities
  • Establish validation standards authoring of standard operating procedures, work instructions and technical presentations in support of a flexible and agile clinical supply chain
  • Perform risk/criticality assessments, technical and GMP related documentation
  • Interacting with Engineering, Quality, Process Development, Quality Control and Production departments in a campus-wide validation team
  • Lead a team of external validation partners
  • Act as Subject Matter Expert (SME) during internal and external audits/inspections

Qualifications
 

Education:

  • Bachelor/Master’s degree in technical or natural sciences

Experience And Skills:

Required:

  • A minimum of 6 years experience in performing process validations within pharma company and demonstrated ability having managed validation projects
  • Profound know-how of Validation requirements according to cGMP regulations
  • Know-how of quality assurance principles
  • Know-how of manufacturing biotechnology processes
  • Experience working in project teams and multiple projects in parallel
  • Excellent interpersonal skills
  • Analytical thinking and problem-solving ability

We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.

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Contact

Email
+44 (0) 20 3589 9300
 

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