Validation Engineer Jobs

• Job Type:Contract

Posted about 4 hours ago

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Required Experience:

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 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.

Knowledge, Skills, and Abilities:

• Good understanding of the global health authority expectations around process validation
• Excellent communication skills, both oral and written
• Experience with development of Process Validation Master Plans, Process Validation Protocols, and Process Validation Reports
• Sound scientific understanding of process validation principles
• Understanding of GMP concepts and quality systems necessary to ensure sound process validation framework
• Good understanding of equipment/system design and validation

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

Responsibilities:

• 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.
• Provide oversight via review and approval, as appropriate, of site level deliverables, including Validation Master Plans, process validation protocols and risk assessments.
• Coordinate responses to health authority questions on process validation.
• Author, review and approve, as needed, various validation documents including, but not limited to, protocols, PPQ plans, final reports and process validation master plans
• Define process validation strategy for upcoming products and support PPQ execution in a multi-site commercial environment.
• 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
• Participate in generation and approval of PPQ enabling deliverables generated during late stage process development and characterization.
• Develop and implement validation policies to define robust process validation program within the cell therapy product lifecycle.
• Respond to site independent process validation troubleshooting issues, questions
• Develop and implement continuous process monitoring strategies and ensure process validation status throughout commercial lifecycle
• Author CMC content for regulatory filings.

Working Conditions:

• This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
• The position will work in an office environment and will need to write complex documents and final reports using a computer.
• This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

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