Engineer II or III, Equipment Engineer

Parexel

1d•Onsite

About The Position

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. We are looking to fill an Engineer position working as a full-time employee of Parexel FSP on assignment onsite at one of our clients located in West Point, PA. This position offers full benefits, sick time, 401K, paid holidays, and paid time off. This position does not offer sponsorship. Description One of our clients’ research laboratories Bioprocess Clinical Manufacturing and Technology (BCMT) Equipment Engineering Team is seeking a specialist Equipment Engineer position. This person will perform various activities regarding equipment maintenance and engineering supporting the Good Manufacturing Practice (GMP) manufacture of bulk clinical supplies. Candidate is expected to work in a team atmosphere in close collaboration with plant personnel, Engineering Maintenance and Utilities personnel, Quality, Environmental, and Safety groups. Some extended hours will be required as well as occasionally supporting off-hour manufacturing. There is the potential for limited weekend work requests to respond to emergencies or time critical operations (less than five times per year). About Parexel Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. Come join us! #LI-DK1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™

Requirements

Previous experience supporting equipment and/or GMP manufacturing facilities, or laboratory areas
Strong teamwork and collaboration
Knowledge of cGMP, Quality Systems, and equipment safety
Highly self-motivated with the ability to work in a fast-paced and dynamic setting
Competency in Microsoft Office Suite, including Excel
Excellent organizational, problem-solving, and project management skills
Ability to sit and stand for extended periods of time
Ability to lift 40 lbs.

Nice To Haves

Technical background on pharmaceutical and biotechnology production equipment
Experience working on teams in a matrixed organization
Ability to read P&IDs (applicable to Engineer 3)
Conducting equipment Lock Out / Tag Out (applicable to Engineer 3)

Responsibilities

Providing maintenance staff with support for all scheduled work associated with designated equipment
Scheduling equipment calibrations and preventative maintenance
Conducting equipment Lock Out / Tag Out
Managing qualified equipment inventories
Supporting equipment validation activities
Providing engineering support for equipment upsets and events
Ensuring GMP status of equipment and facilities
Conducting Equipment Qualification Periodic Review for designated equipment
Creating equipment and facility work notifications for corrective maintenance
Maintaining/managing equipment parts lists for designated equipment, ordering special parts when needed.
Managing small parts/accessories for equipment
Supporting environmental and safety initiatives