Sr. Qualification/Validation Engineer - OQSIE
Fremont, CA 94555
About the Job
Duties:
Lead/manage validation projects including:
-Provide risk assessment for new systems and changes to existing systems
-Write validation plans, protocols and reports
-Execute and provide reviews of validation protocols and validation periodic monitoring
-Lead or participate in project team including the supervision of validation contractors
-Provides estimates of validation resource requirements.
Skills:
-Greater than 10 years of relevant cGMP biopharmaceutical manufacturing environment experience in validation/qualification
-At least 5 years must be recent experience with validation/qualification of typical manufacturing equipment and/or computer systems at a multi-product biopharmaceutical manufacturing facility.
-Experience in 3 or more GMP validation disciplines (Process Equipment, Utility (including HVAC), Laboratory, Automation, Computer Systems, Sterilization, Sterile Filling/Isolator) with advanced technical knowledge
-Knowledge of Validation Lifecycle Approach (URS, FRS, FAT/SAT, Commissioning Protocols, etc) guidelines, international regulatory requirements and standards (GMP, ICH Q7, Q8, Q9, Q10 and other international regulatory requirements
-Proven skill in use of thermal mapping equipment in validating, Autoclaves,Tanks, and other temperature controlled units
-Validation experience using risk based approach (FMEA, PHA, etc)
-Excellent technical writing and verbal communication skills
-Ability to read/interpret engineering drawings and design documents
-Ability to work as part of a high performing team and collaborate effectively with staff at all levels. Must have well-developed interpersonal skills with the ability to establish highly functional relationships with diverse personalities both within and outside the company.
-Demonstrated ability to manage multiple activities while maintaining a high level of organization
-Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision.
-Experienced in Microsoft Office Suite
Education:
Bachelors Degree in science or engineering, from an accredited university or college. Advanced degree, MBA or Masters in science or engineering is preferred.
Lead/manage validation projects including:
-Provide risk assessment for new systems and changes to existing systems
-Write validation plans, protocols and reports
-Execute and provide reviews of validation protocols and validation periodic monitoring
-Lead or participate in project team including the supervision of validation contractors
-Provides estimates of validation resource requirements.
Skills:
-Greater than 10 years of relevant cGMP biopharmaceutical manufacturing environment experience in validation/qualification
-At least 5 years must be recent experience with validation/qualification of typical manufacturing equipment and/or computer systems at a multi-product biopharmaceutical manufacturing facility.
-Experience in 3 or more GMP validation disciplines (Process Equipment, Utility (including HVAC), Laboratory, Automation, Computer Systems, Sterilization, Sterile Filling/Isolator) with advanced technical knowledge
-Knowledge of Validation Lifecycle Approach (URS, FRS, FAT/SAT, Commissioning Protocols, etc) guidelines, international regulatory requirements and standards (GMP, ICH Q7, Q8, Q9, Q10 and other international regulatory requirements
-Proven skill in use of thermal mapping equipment in validating, Autoclaves,Tanks, and other temperature controlled units
-Validation experience using risk based approach (FMEA, PHA, etc)
-Excellent technical writing and verbal communication skills
-Ability to read/interpret engineering drawings and design documents
-Ability to work as part of a high performing team and collaborate effectively with staff at all levels. Must have well-developed interpersonal skills with the ability to establish highly functional relationships with diverse personalities both within and outside the company.
-Demonstrated ability to manage multiple activities while maintaining a high level of organization
-Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision.
-Experienced in Microsoft Office Suite
Education:
Bachelors Degree in science or engineering, from an accredited university or college. Advanced degree, MBA or Masters in science or engineering is preferred.
Source : OQSIE
