Computer Systems Validation

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.

Requirements:

Knowledge of science is 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, and 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 execution 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