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Form of workJob Description: Principal Quality Assurance Validation Specialist--Computer Systems
Location: Devens, MA
Position Summary
**Highly experienced computer systems and equipment validation professional with strong compliance mindset.
Role will oversee the validation of equipment and computer systems, including, but not limited to, process automation systems, manufacturing execution systems (MES), Temperature controlled units, analytical instruments.
Detailed Position Responsibilities:
• Oversee the qualification of process automation systems, laboratory and manufacturing instruments, manufacturing execution systems, databases.
• Interface with Engineering, Validation, and end user groups as a QA subject matter expert to provide technical validation guidance related to GxP compliance, design and requirements development, testing, system administration, data management, and risk-management.
• Oversee the development, implementation, and maintenance of site procedures and policies for Validation, aligning with global policies and procedures.
• Review and approve validation plans, qualification protocols and test scripts, user acceptance testing, reports, change management, and authorization for use documentation.
• Ensure that all regulatory and cGMPs compliance items related to validation are satisfied and ensures Validation Master Plan (VMP) adherence.
• Review and approve exceptions associated with the qualification and startup of the Devens Cell Therapy Facility and participate in resulting investigations and correction / corrective action planning.
• Verify compliance with applicable Client Policies, Guidelines and Directives and ensures consistency with other site procedures and/or specifications.
Required Experience and Education:
• Knowledge of science generally attained through studies resulting in a Bachelor’s degree in a scientific or engineering discipline or its equivalent.
• A minimum of 9 years' experience in an environment governed by cGMPs, in validation (equipment, facilities, Computer systems) or Quality Assurance Validation role overseeing equipment and computerized systems validation
• Detailed knowledge of cGMP and regulatory requirements for validation of equipment, computerized systems, and processes.
• Firm understanding of quality systems
• Proficiency in the use of software applications including electronic validation documentation systems (such as ValGenesis, Maximo)
• Demonstrated interpersonal, communication, and motivation skills.
• Must be action-oriented, customer-focused, and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, and analytical thinking.
• Knowledge of temperature mapping, manufacturing executions systems such as Syncade and distributive control systems such as DeltaV is required
• Effective written and verbal communication skills
Development Value
• Gain experience in Cell Therapy and operations
• Interface with many functional areas including Manufacturing Sciences and Technology, Digital Plant, Manufacturing, Validation, Quality
Location: Devens, MA
Position Summary
**Highly experienced computer systems and equipment validation professional with strong compliance mindset.
Role will oversee the validation of equipment and computer systems, including, but not limited to, process automation systems, manufacturing execution systems (MES), Temperature controlled units, analytical instruments.
Detailed Position Responsibilities:
• Oversee the qualification of process automation systems, laboratory and manufacturing instruments, manufacturing execution systems, databases.
• Interface with Engineering, Validation, and end user groups as a QA subject matter expert to provide technical validation guidance related to GxP compliance, design and requirements development, testing, system administration, data management, and risk-management.
• Oversee the development, implementation, and maintenance of site procedures and policies for Validation, aligning with global policies and procedures.
• Review and approve validation plans, qualification protocols and test scripts, user acceptance testing, reports, change management, and authorization for use documentation.
• Ensure that all regulatory and cGMPs compliance items related to validation are satisfied and ensures Validation Master Plan (VMP) adherence.
• Review and approve exceptions associated with the qualification and startup of the Devens Cell Therapy Facility and participate in resulting investigations and correction / corrective action planning.
• Verify compliance with applicable Client Policies, Guidelines and Directives and ensures consistency with other site procedures and/or specifications.
Required Experience and Education:
• Knowledge of science generally attained through studies resulting in a Bachelor’s degree in a scientific or engineering discipline or its equivalent.
• A minimum of 9 years' experience in an environment governed by cGMPs, in validation (equipment, facilities, Computer systems) or Quality Assurance Validation role overseeing equipment and computerized systems validation
• Detailed knowledge of cGMP and regulatory requirements for validation of equipment, computerized systems, and processes.
• Firm understanding of quality systems
• Proficiency in the use of software applications including electronic validation documentation systems (such as ValGenesis, Maximo)
• Demonstrated interpersonal, communication, and motivation skills.
• Must be action-oriented, customer-focused, and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, and analytical thinking.
• Knowledge of temperature mapping, manufacturing executions systems such as Syncade and distributive control systems such as DeltaV is required
• Effective written and verbal communication skills
Development Value
• Gain experience in Cell Therapy and operations
• Interface with many functional areas including Manufacturing Sciences and Technology, Digital Plant, Manufacturing, Validation, Quality
