Kelly Services • Frederick, MD 21705
Job #2688409169
Process Validation Scientist
Demonstrate specific upstream cell culture and downstream purification unit operations knowledge in support of bioprocessing of large molecule biologics
Lead Process Validation (Stage 3) activities including:
Process validation strategies, protocols/reports review/approval timely generation of Chemistry Manufacturing and Controls (CMC) documentation
Collaboration between Manufacturing Sciences and Technology (MS&T), Manufacturing Regulatory and Quality provides statistical support for product monitoring using techniques including statistical process control, process capability analysis, non-linear and linear regression and significant tests.
Process investigation PV impact assessment strategies
Collaborate with global process validation team
Communicate CPV trends to Quality Management and CMC teams.
Present/defend process validation packages and strategies during audits and inspections.
Review/approve technical reports and deliver presentations utilizing sound compliance reasoning and interpretation of the available data
Essential for the role:
Bachelor's Degree preferably in Science or Engineering. Master's Degree or PhD preferred.
At least ten (10) years of overall experience in Scientific / Biotech / Pharmaceutical field with at least five (5) years of experience in Process Validation.
Comprehensive knowledge PPQ and CPV regulatory expectations.
Fundamental understanding of upstream and downstream process units for biopharmaceutical products.
Broad understanding of Chemistry Manufacturing and Controls (CMC) activities and responsibilities with respect to Process Validation/Process Performance Qualification
Knowledge of GMP manufacturing principles and documentation
Proficient in statistical tools and techniques commonly used in the Biotech industry.
Ability to apply critical thinking to solve problems and work independently
Strong interpersonal and communication skills.
#P2
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (~~~) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
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Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
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