Address
Form of work Responsibilities:
Requirements:
- 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
- dministration, data management, and risk-management.
- Oversee the development, implementation, and maintenance of site procedures and policies for Validation,
- ligning 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
- nd 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.
- 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
