Engineer II or III, Biotechnology Equipment Engineer

Location: Northeast, Pennsylvania, United States of America

Employment Type: Local Office

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).

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

Qualifications

• Engineer 2, Bachelor’s degree in Engineering with 1-2 years of relevant experience

• Engineer 3, Bachelor’s degree in Engineering with 3-5 years of relevant experience

Required Skills and Experience

• 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. 

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Desired Skills and Experience

• 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)

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!

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