Our client, a leading pharmaceutical company, is hiring a Validation Engineer consultant on a contract basis.
Reporting to the Vector Process Validation Lead within Global Manufacturing Science and Technology, this role will define and implement the process validation strategy and studies for clients lentiviral vector products. This role will be responsible for the development of process validation master plans, process validation study design, protocols, and reports and implementation at both internal and external manufacturing sites. The role will provide technical oversight for initial process performance qualification (PPQ) as well as throughout the product life cycle. Candidate will interface with the Site MSAT and other cross-functional groups to ensure the process validation strategy is appropriate. The candidate will also contribute to process validation-related investigations, troubleshooting efforts, and responses to emerging requirements or questions during health authority interactions. Candidate will participate in the development of process characterization and process control strategies as needed to ensure that the control strategies are consistent with the process validation standards and manufacturing requirements.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
• Sound scientific understanding of process validation principles
• Good understanding of the global health authority expectations around process validation
• Understanding of GMP concepts and quality systems necessary to ensure sound process validation framework
• Good understanding of equipment/system design and validation
• Excellent communication skills, both oral and written
• Experience with development of Process Validation Master Plans, Process Validation Protocols, and Process Validation Reports
Education and Experience:
• Required Bachelors Degree in Life Sciences or Chemical Engineering
• Minimum 5 years of experience in pharma/biotech industry, min 2 years of validation experience in a GMP environment
• Preference will be given to candidates with Cell Therapy experience
DUTIES AND RESPONSIBILITIES:
• Develop and implement validation policies to define robust process validation program within the cell therapy product lifecycle.
• Participate in generation and approval of PPQ enabling deliverables generated during late stage process development and characterization.
• Define process validation strategy for upcoming products and support PPQ execution in a multi-site commercial environment.
• Author CMC content for regulatory filings.
• Represent validation on contract manufacturing projects, including vendor selection, process transfer and process validation. Direct responsibility for validation activities at contract manufacturing organizations, including validation gaps assessments during CMO selection and tech transfers
• Provide oversight via review and approval, as appropriate, of site level deliverables, including Validation Master Plans, process validation protocols and risk assessments.
• Develop and implement continuous process monitoring strategies and ensure process validation status throughout commercial lifecycle
• Respond to site independent process validation troubleshooting issues, questions
• Coordinate responses to health authority questions on process validation.
• Work with process, analytical development and MSAT groups to review, approve the development of process characterization and process control strategies as needed to ensure that the control strategies are consistent with the process validation standards and manufacturing requirements.
• Author, review and approve, as needed, various validation documents including, but not limited to, protocols, PPQ plans, final reports and process validation master plans
Pay Range $70-75