IVD Process Validation SME

About the role

Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge and expertise to augment and supplement their work. Their vision is to closely align clients’ needs with the best resources available in the marketplace. They take proactive, preventative and corrective action and create a roadmap for ongoing future improvement by identifying, integrating and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages. MEC offers short or long-term support — from high-end leaders, managers and consultants to skill-set engineering staff and SMEs. Their mission is to inspire positive cultural change from within and always exceed clients’ expectations.

Responsibilities

• Lead development of the Process Validation strategy for IVD manufacturing
• Coordinate process mapping, including documenting the current RUO process and identifying gaps to address for IVD compliant process
• Coordinate and contribute technical expertise to establish the process validation strategy to address:
  • Gaps identified during process mapping
  • Identification of critical process parameters (CPPs)
  • Identification of critical quality attributes (CQAs)
  • Risk-based approach to meet compliance requirements aligned with client product timelines and business objectives
• Establish the validation framework including:
  • IQ / OQ / PQ approach
  • Validation lifecycle and deliverables
  • Additional activities required for IVD and assay manufacturing
• Developing batch records to document each manufacturing run
• Establishing Manufacturing instructions for routine use
• Establishing criteria for release of clinical study kits
• Establish Process Validation Master Plan (PVMP) covering:
  • Process scope and boundaries
  • Validation requirements
  • Deliverable structure and sequencing
• Translate process validation expectations into required work instructions, templates, validation documentation framework
• Work cross-functionally with stakeholders, including Operations, R&D and Quality.
• Lead team assigned to execute established PVMP.

Qualifications

• Strong understanding of medical device regulatory requirements (e.g., FDA, ISO 13485, ISO 14971) and risk management principles.
• 10+ years experience in process validation within medical device or IVD industry
• Deep expertise in:
  • IQ/OQ/PQ methodologies
  • Process validation lifecycle
  • Additional process validation activities required for IVD and assay manufacturing such as: validating reagent / immunoassay manufacturing (buffers, antibody reagents) and reagent CQAs, stability, and lot-to-lot consistency.
  • Batch record requirements
  • Manufacturing instructions
  • Criteria for release of clinical study kits
• Experience developing and executing Process Validation Master Plans.
• Experience supporting manufacturing scale-up or product commercialization.
• Demonstrated experience working effectively with all levels of the organization, from executive level leaders to engineering staff.
• Cross-functional project team leadership experience.
• Strong demonstrated communication and interpersonal skills.
• Ability to work independently with minimal supervision and maintain confidentiality of sensitive records.
• Demonstrated ability to deliver results on compressed timelines.
• Hands-on experience with Research Use Only and IVD QMS processes strongly preferred.