PRINCIPAL QUALITY ASSURANCE CSV SPECIALIST DEVENS, MA Hybrid Work Schedule: 50% Onsite
Top Skills Required:
Computer Systems Validation.
Proactive, self-motivated, and needing minimum supervision.
Deviations and investigations.
MES systems preferred; Delta V will work w/coding experience.
Knowledge of science generally attained through studies resulting in a bachelor's degree in a scientific or engineering discipline.
A minimum of 6 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.
Effective written and verbal communication skills Development Value.
Interface with many functional areas including Manufacturing Science and Technology, Digital Plant, Manufacturing, Validation.
Knowledge of applicable business systems including: Veeva Vault is desirable.
Highly experienced computer systems validation professional with strong compliance mindset.
Role will support the validation of computerized systems, including, but not limited to, process automation systems (DeltaV), manufacturing execution systems (MES), databases, Analytical Equipment, and IT infrastructure.
Oversee the qualification of process automation systems, Analytical and manufacturing instruments, manufacturing execution systems, databases, and IT infrastructure.
Interface with MS&T, Validation, and end user groups as a Quality 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.
Support the implementation and maintenance of Computer System changes, aligning with site compliance policies and procedures.
Review and approve 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.
Review and approve exceptions associated with the qualification and participate in resulting investigations and correction / corrective action planning.
Verify compliance with applicable Policies, Guidelines and Directives and ensures consistency with site procedures and/or specifications.
This 6+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Cheryl: cambrose@alphaconsulting.Com
ALPHA'S REQUIREMENT #23-00194
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE