Validation Engineer
Contract: 3+ months duration with possible extensions
Location: Beloit, WI - onsite
Automated Systems, Inc. is seeking a dedicated Validation Engineer to work with one of our leading pharmaceutical manufacturing clients located in Beloit, WI.
In this role, the Validation Engineer will be assisting in establishing Commissioning and Qualification (C&Q) policies/strategies, lead specific C&Q activities for pharmaceutical manufacturing equipment and processes, ensuring compliance with quality standards/requirements, and industry standards (FDA, EMA, ISO, ICH, etc.). All projects and duties will be completed in compliance with applicable cGMP, FDA, and all other regulatory agencies standards.
Job Role Duties and Responsibilities
- Assists in the change management of facilities, utilities, systems, equipment (FUSE), and processes.
- Able to drive C&Q project completion and compliance in a challenging and fast-moving environment in a timely and efficient manner.
- Assists in developing and managing the C&Q Programs/Processes including generating and maintaining site and project C&Q plans, overseeing C&Q schedules/activities, and coordinating various C&Q activities with cross functional teams.
- Work with cross-functional teams in design reviews, impact assessments, generation of requirements, risk assessments, and other identified C&Q deliverables.
Education, Experience and Skill Requirements
Bachelor's degree in Engineering or a Science-related field with 3+ years of progressive experience in the pharmaceutical industry with at least 2 of those years acting in a Qualification/Validation role; or equivalent combination of education and experience.
Experience working with current validation principles, standard concepts, practices and procedures, and
Relevant working experience with the requirements and regulations in a cGMP regulated environment is necessary.
Demonstrated proficiency in five or more validation areas required.
Experience with Statistical Analysis preferred.
Strong collaboration, communication, and presentation skills required.
Expert-level proficiency with Microsoft Office (Word, Excel, PowerPoint, and Outlook) is required.