Commissioning, Qualification, and Validation Engineer

TRS is currently seeking Commissioning, Qualification, and Validation Engineer for a Life Science Company:

DUTIES:
Provide technical support to site Validation personnel, as well as work with Engineering and QA to ensure reliable and predictable equipment and process operation.
In-depth understanding of the governing standards for medical device sector.
Act as Project SME for relevant CQV processes, including ASTM E2500, which will be utilized for CQV document creation and field execution.
Create and manage all documentation produced for the Project, including Plans, SOPs, Strategies, DQ, QRA, RTM, FAT, RV, SAT, IOC, IOQ, and all supporting Final Reports.
Manage execution of all testing from FAT through to IOQ.
Prepares & presents project status & targets.
Collaborate with multiple departments including Manufacturing, Facilities, Engineering, Quality Control, Validation, Quality Assurance, and Regulatory to facilitate agreement on equipment and process operational parameters, test requirements, and acceptance criteria.
Generation, execution, and closeout of Commissioning and Validation documentation, including test plans, procedures, and protocols.
Review and approval of a variety of validation lifecycle documents, include but are not limited to validation and/or project plans, user requirement specifications, SOPs, maintenance documentation, investigation reports, deviation resolution, CAPA closeout, etc.
Provide leadership and technical support to Quality & Regulatory Compliance (QRC) and Manufacturing Operations staff on all aspects of the manufacturing and laboratory process controls.
Communicates current and applicable good manufacturing practices (GMP) and to business partners.
Executes functions needed to support change control activities and document management requirements.
Collaborates with business partners and peers to define validation and change control activity requirements for individual projects.
Establishes and communicates requirements for validation execution and documentation through daily interactions, training, and so on.
Assists and supports the development of equipment and process validations by participating in the design of feasibility studies that assess manufacturing capability/reliability.
Writes/revises or reviews /approves a variety of validation lifecycle documents. Document types include but are not limited to validation plans, validation protocols, equipment qualification (IQ/OQ/PQ), process validation, cleaning validations, requirement specifications, method validations, SOPs, work instructions and forms, investigations, validation deviations, CAPAs, any pertinent test data, and validation reports.


REQUIREMENTS:
Bachelor’s degree or equivalent in Engineering, Science, or related discipline
7+ years of experience working in a GMP manufacturing facilities role.
Ability to effectively communicate with all levels within the organization
Ability to build collaborative relationships with colleagues and clients
Demonstrated effectiveness in a dynamic, fast-paced, and ever-changing environment.
Able to deal with pressure, take on challenging projects, manage competing priorities, and anticipate problems in advance


TRS Staffing Solutions is an Equal Opportunity Employer that recognizes the value of a diverse workforce. Employment decisions are based on job related criteria and not on the basis of any unlawful criteria. We ensure equal access to employment opportunities, services, and programs.

Must have legal right to work in the United States. We thank all applicants for their interest; however, only those selected for interviews will be contacted.

For more information, or to apply, contact Stephanie Warneke at Stephanie.Warneke@trsstaffing.com