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Description:
The Validation Engineer functions as the lead for all maintenance, engineering, and validation activities within the clinical packaging area.
Equipment, facility, utilities and cleaning are within the scope of responsibility.
The incumbent will be the primary liaison with the operations, engineering services, and third party vendors for executing activities within area of responsibility.
The incumbent will also be responsible for the management of the area Engineering Technician.
All responsibilities should be executed in a manner to ensure that product quality is maintained at the appropriate level to meet R&D and Corporate Quality Standards/Expectations.
Manage all departmental capital projects and miscellaneous engineering activities.
Work with in-house functional support and outside vendors to coordinate required services.
Manage all equipment, facility, utility and cleaning validation activities.
Maintain the Validation Master Plan (VMP) as appropriate.
Responsible for Validation Change Control documentation and managing the electronic tracking system.
Identify and implement opportunities to reduce costs, increase flexibility, and generate additional capacity through process improvement initiatives.
Interface with area managers from the Operations and Quality functions through the Validation Review Boards.
Ensure the integrity, quality, adequacy, and appropriateness of validation documentation through comprehensive document review.
Ensure thorough investigation and timely resolution of issues related to equipment, facilities, and utilities.
Manage validation related, quality improvement projects to foster R&D compliance to regulatory, corporate and department requirements.
Represent department in quality audits, both internal and external, in regards to validation and engineering compliance.
Cultivate and foster strong working relationships with packaging operations and engineering validation disciplines.
Initiate change requests (CR) for Standard Operating Procedures (SOP) in support of equipment and operations processes.
Supervise FTE engineering technicians and contract validation engineering as needed.
Ensure employee resource allotment and workload requirements are balanced to meet the forecasted needs of the business.
Partners with all levels of key business functions to ensure packaging equipment has the functionality and is equipped to support new and ongoing clinical studies.
Responsible for ensuring equipment reliability expectations are achieved in a high-throughput, clinical packaging facility.
Continually evaluates and balances short term production support needs with long term strategic objectives of the department.
Qualifications
Bachelor's Degree, a BS in an engineering discipline.
4-year pharma, health care, or regulated industry
5+ years pharma experience with 2+ years of validation experience
5+ years combined work experience in validation and/or engineering positions within the pharmaceutical area.
Knowledge/experience in creating and executing validation documents in VMS.
Knowledge/experience in engineering and financial systems.
General understanding of Engineering Standards and Specifications.
General understanding of pharmaceutical packaging equipment
Shift schedule: Typical M-F with some opportunity for OT depending on workload
Benefits:
Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.
Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first of the month following at least 1 calendar year after employment begins.
Synectics is an equal opportunity employer.
Synectics is a leading staffing and workforce solutions company dedicated to connecting exceptional talent with top organizations. We specialize in IT, engineering, finance, healthcare, and professional services recruitment, offering both contract and permanent staffing solutions. With a people-first approach, we focus on understanding the unique needs of our clients and candidates to create long-term, successful matches. Our mission is to empower businesses with the right talent while helping professionals achieve rewarding career opportunities