Novozen Healthcare LLC
Job Title:
Senior Validation Engineer (CQV)
Job Summary:
We are seeking an experienced Senior Validation Engineer (CQV) to lead commissioning, qualification, and validation (CQV) activities for pharmaceutical manufacturing systems, utilities, and equipment. The ideal candidate will have a solid understanding of cGMP, FDA, and EU regulatory requirements and hands‑on experience executing validation deliverables within a GMP environment.
Key Responsibilities
Lead and execute CQV activities for equipment, utilities, and process systems (e.g., bioreactors, autoclaves, CIP/SIP, HVAC, water systems, etc.).
Prepare and review Validation Protocols (IQ/OQ/PQ), Test Scripts, and Summary Reports.
Support project planning, scheduling, and risk assessments related to validation scope.
Collaborate with cross‑functional teams including QA, Manufacturing, Engineering, and Maintenance to ensure compliance with validation and quality standards.
Ensure adherence to GMP, GAMP 5, FDA, and ICH guidelines throughout all validation activities.
Support change control, deviations, and CAPA investigations related to validation.
Maintain and update validation master plans (VMP) and associated documentation.
Mentor and guide junior validation engineers in executing CQV deliverables.
Required Qualifications
Bachelor’s degree in Engineering, Biotechnology, Pharmaceutical Sciences, or related field.
Minimum 5 years of experience in CQV / Validation within the pharmaceutical or biotech industry.
Strong understanding of GMP, GAMP 5, 21 CFR Part 11, and ISPE guidelines.
Hands‑on experience with equipment qualification, process validation, and cleaning validation.
Excellent documentation, analytical, and problem‑solving skills.
Strong communication and teamwork abilities.
Preferred Skills
Experience with automation systems (DeltaV, Rockwell, Siemens).
Exposure to cell & gene therapy, biologics, or sterile manufacturing environments.
Knowledge of validation lifecycle management tools (e.g., ValGenesis, Kneat).
Seniority level
Mid‑Senior level
Employment type
Contract
Job function
Science and Engineering
Industries
Pharmaceutical Manufacturing and Biotechnology Research
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Senior Validation Engineer (CQV)
Job Summary:
We are seeking an experienced Senior Validation Engineer (CQV) to lead commissioning, qualification, and validation (CQV) activities for pharmaceutical manufacturing systems, utilities, and equipment. The ideal candidate will have a solid understanding of cGMP, FDA, and EU regulatory requirements and hands‑on experience executing validation deliverables within a GMP environment.
Key Responsibilities
Lead and execute CQV activities for equipment, utilities, and process systems (e.g., bioreactors, autoclaves, CIP/SIP, HVAC, water systems, etc.).
Prepare and review Validation Protocols (IQ/OQ/PQ), Test Scripts, and Summary Reports.
Support project planning, scheduling, and risk assessments related to validation scope.
Collaborate with cross‑functional teams including QA, Manufacturing, Engineering, and Maintenance to ensure compliance with validation and quality standards.
Ensure adherence to GMP, GAMP 5, FDA, and ICH guidelines throughout all validation activities.
Support change control, deviations, and CAPA investigations related to validation.
Maintain and update validation master plans (VMP) and associated documentation.
Mentor and guide junior validation engineers in executing CQV deliverables.
Required Qualifications
Bachelor’s degree in Engineering, Biotechnology, Pharmaceutical Sciences, or related field.
Minimum 5 years of experience in CQV / Validation within the pharmaceutical or biotech industry.
Strong understanding of GMP, GAMP 5, 21 CFR Part 11, and ISPE guidelines.
Hands‑on experience with equipment qualification, process validation, and cleaning validation.
Excellent documentation, analytical, and problem‑solving skills.
Strong communication and teamwork abilities.
Preferred Skills
Experience with automation systems (DeltaV, Rockwell, Siemens).
Exposure to cell & gene therapy, biologics, or sterile manufacturing environments.
Knowledge of validation lifecycle management tools (e.g., ValGenesis, Kneat).
Seniority level
Mid‑Senior level
Employment type
Contract
Job function
Science and Engineering
Industries
Pharmaceutical Manufacturing and Biotechnology Research
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