Scientist
Description
Process Validation Scientist - Official Title/Role
1st Shift M- F 9 - 5 (at site)
Preferred Experience
Masters degree
3 - 6 years experience in biopharmaceutical Process Validation, Continued Process Verification role either as practitioner or Quality Assurance
Strong technical writing and collaboration
Regulatory experience is a plus
Statistics experience is a plus
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Additional Details
Process Validation Scientist - Official Title/Role
- 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
- 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.
1st Shift M- F 9 - 5 (at site)
Preferred Experience
Masters degree
3 - 6 years experience in biopharmaceutical Process Validation, Continued Process Verification role either as practitioner or Quality Assurance
Strong technical writing and collaboration
Regulatory experience is a plus
Statistics experience is a plus
External Job Title try { var fgTooltip = new FG.Tooltip({ element: $('#cf_descz19092616223153525437924'), text: "This\x20title\x20is\x20known\x20in\x20the\x20market\x20place\x20and\x20will\x20help\x20suppliers\x20source\x2Frecruit\x20potential\x20candidates" }).initialize(); } catch(err) {}
Additional Details
- Manager's Requested Bill Rate : (No Value)
- Does the position allow for the worker to be virtual/remote? : No
- Critical Position? : No
- Career Level : D
- External Job Title : (No Value)
-
Seniority level
Mid-Senior level -
Employment type
Contract -
Job function
Research, Analyst, and Information Technology -
Industries
Staffing and Recruiting
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