V alidates and re-validates new or modified products, equipment, or systems. The Validation Engineer will interface with our clients and be responsible for preparing and executing commissioning and qualification documents for a variety of utility, facility, and process equipment. This level of engineer is expected to have beginning level knowledge of the subject matter.
This role will include both document development and field execution of test protocols, including FATs, SATs, CTPs, IQs, OQs, PQs, PVs.
A working knowledge of, and experience generating life cycle documentation such as URSs, FRSs, and SDSs.
Required experience with good documentation practices, cGMP, & FDA CQV methods and systems, ability to read engineering documents, set priorities, and work on multiple projects simultaneously.
This position also requires a working knowledge of pharmaceutical and biotechnology systems, as the role will involve identification, interface and operation of this equipment.
Requires strong verbal communication, technical writing skills and word processing skills.
2+ years of experience with increasing responsibility in life sciences, biotech or other FDA regulated validation involving equipment.
Experience including clean utilities, facility systems, process support systems, bioprocess manufacturing and packaging equipment is desirable.
Good working knowledge of biologic unit operations, including fermentation and purification methods and equipment.
BS degree in science, engineering, manufacturing technology or closely related field or equivalent experience in a manufacturing facility.
Barry-Wehmiller is an equal opportunity employer. M/F/D/V This organization uses E-Verify.
Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.
Design Group US Inc