Quality - Principal Quality Assurance Validation Specialist Computer Systems

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
Val Genesis, 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 Delta

V 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