Validation Engineering Specialist II

pbuJob Description/u/b/pp/pdivdivpAs part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer./pp/ppbHow will you make an impact?/b/p/divdivpspanspanProvide specialized validation knowledge and information, which is directly needed to support operations and clients. Complete protocols and reports related to the validation of manufacturing processes, packaging processes (including serialization), /spanspanContinues Process Verification (CPV), /spanspanequipment qualification and cleaning. Ensure documents conform to all /spanspanThermoFisher/spanspan Standard Operating Procedures (SOPs), client requirements and Good Manufacturing Practices./span/spanspan /span/p/divdivpspan /span/p/divdivpbspanWhat will you do/span/b bspan:/spanspan /span/bspan /span/p/divdivullipspanspanPrepare and execute validation protocols (new and existing clients) and /spanspanwriting/spanspan reports./span/spanspan /span/p/lilipspanspanPrepare Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) for more complex equipment, /spanspanfacilities/spanspan and computer systems. /span/spanspan /span/p/lilipspanspanReview/verify data and /spanspanperforms/spanspan statistical analysis. /span/spanspan /span/p/lilipspanspanMonitor the production scheduling and coordination of validation activities as /spanspanrequired/spanspan /span/spanspan /span/p/lilipspanspanProvide technical/validation /spanspanexpertise/spanspan and support to Quality Operations/Business or Project management/operations/Pharmaceutics and Process Technology (PPT). /span/spanspan /span/p/lilipspanspanDocument review of peer protocols and reports./span/spanspan /span/p/lilipspanspanMaintain cleaning program and trending cleaning results./span/spanspan /span/p/lilipspanspanPerform 5 years qualification reviews./span/spanspan /span/p/lilipspanspanSupport equipment swabbing./span/spanspan /span/p/li/ul/divdivullipspanspanAttend client meetings as validation representative (as /spanspanrequired/spanspan)/span/spanspan /span/p/lilipspanspanSupport special projects (as /spanspanrequired/spanspan)/span/spanspan /span/p/lilipspanspanMaintain a safe working environment and report potential hazards./span/spanspan /span/p/lilipspanspanPerform alternating or rotating shifts (/spanspanif/spanspan /spanspanrequired/spanspan)/span/spanspan /span/p/li/ul/divdivpspan /span/p/divdivpbspanHow will you get here:/span/bspan /span/p/divdivpbspanEducation:/spanspan /span/bspan /span/p/divdivpspanspanBSc in Chemistry, Pharmacy, Engineering, or related field. /span/spanspan /span/p/divdivpspan /span/p/divdivpbspanExperience:/spanspan /span/bspan /span/p/divdivpspanspanMinimum 3 years’ experience in validation within the pharmaceutical industry. /span/spanspan /span/p/divdivpspanspanPrevious/spanspan experience in statistical analysis preferable. /span/spanspan /span/p/divdivpspanspan /span/spanbr /bspanEquivalency/span/bispan:/spanspan /span/ispan /span/p/divdivpspanspanEquivalent combinations of education, training, and relevant work experience may be considered. /span/spanspan /span/p/divdivpspan /span/p/divdivpbspanKnowledge, /spanspanSkills/spanspan and Abilities/spanspan:/span/bspan /span/p/divdivpspanspanStrong written and oral skills/spanspan. /spanspanDetail oriented and organized, with a high degree of accuracy and thoroughness/spanspan. /spanspanExcellent interpersonal skills, /spanspancommunication/spanspan and organizational skills/spanspan. /spanspanStrong judgment, decision making and trouble shooting skills/spanspan. /spanspanAbility to multi-task, meeting tight deadlines in a /spanspanfast paced/spanspan environment/spanspan. /spanspanMini-T/spanspanab/spanspan and data analysis knowledge an asset. Demonstrated computer /spanspanproficiency/spanspan with Microsoft Office programs/spanspan. /spanspanProficiency/spanspan with the English Language. /span/spanspan /span/p/divdivpspan /span/p/divdivpbspanPhysical Requirements: /span/bspan /span/p/div/divdivpspanspanPosition requires ordinary ambulatory skills and physical coordination sufficient to move about lab/lab office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally./span/spanspan /span/pp/ppOur Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued./ph2Apply today! http://jobs.thermofisher.com/h2/div