Temporary Principal Quality Assurance Validation Specialist – Computer Systems (21-17544)
Job Description
Job Description: Position Summary
**Highly experienced computer systems validation professional with strong compliance mindset. Role will oversee the validation of computerized systems, including, but not limited to, process automation systems, manufacturing execution systems (MES), laboratory instruments, databases, and IT infrastructure.
Detailed Position Responsibilities
• Oversee the qualification of process automation systems, laboratory and manufacturing instruments, manufacturing execution systems, databases, and IT infrastructure.
• 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, software testing, system administration, data management, and risk-management.
• Oversee the development, implementation, and maintenance of site procedures and policies for Computer System 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.
Desired Experience
• 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 a computer systems validation or quality assurance validation role overseeing electronic 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 computers and software applications including electronic validation documentation systems (such as ValGenesis and ALM)
• 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 manufacturing executions systems such as Syncade and distributive control systems such as DeltaV is required
• Knowledge of applicable business systems including: SAP, LIMS, Maximo and Veeva Vault is desirable
• Effective written and verbal communication skills
Development Value • Gain experience in Cell Therapy start-up and operations
• Interface with many functional areas including Manufacturing Technology, Digital Plant, Manufacturing, Validation, Quality
Additional Job Requirements:
None
How to Apply
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