Job Description

　　As 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.

　　How will you make an impact?

　　Provide specialized validation knowledge and information needed to support operations and clients. Complete protocols and reports related to facility, utility, equipment, and associated control systems qualification. Responsible for validation project management. Ensure documents conform to all Thermo Fisher Standard Operating Procedures (SOPs), client requirements and current Good Manufacturing Practices .

　　What will you do?

　　Provide leadership to Validation Engineering Specialist I, II and III by supporting problem solving and solution generation on projects, training/mentoring, and supporting project progression.

　　Prepare and execute validation protocols (new and existing assets) and writing reports.

　　Review documents from team members and act as validation manager designate.

　　Provide guidance to junior members on various validation requirements and strategy (through team meetings and individual interactions).

　　Attend FATs and facilitate SATs.

　　Undertake validation project management for multiple concurrent projects, including but not limited to internal and external resource management, vendor follow-up, manage schedules and budgets.

　　Monitor production schedules and coordinate validation activities as required.

　　Work with technical SMEs and provide accurate timelines to project engineers for validation activities.

　　Coordinate overall CapEx project deliverables with stakeholders, as required.

　　Report on KPIs to validation manager, including but not limited to percent complete, earned value, right first time.

　　Review and approve assessments, deviations, change controls and protocols/reports.

　　Provide input to sustain and evolve IQ/OQ/PQ templates & methodology.

　　Review/verify data and performs statistical analysis.

　　Attend client meetings as validation lead (as required).

　　Provide audit and regulatory support.

　　Lead/facilitate technical investigations and Corrective Action Preventative Action (CAPA) implementation.

　　Support special projects (as required)

　　Maintain a safe working environment and report potential hazards.

　　Perform alternating or rotating shift work (as required)

　　How will you get here?

　　Education:

　　Bachelor’s degree in science, Engineering, or related field.

　　Experience:

　　Minimum experience of 7 years in validation within the pharmaceutical industry.

　　Previous experience in project management and/or statistical analysis preferable.

　　Equivalency:

　　Equivalent combinations of education, training, and relevant work experience may be considered.

　　Knowledge, Skills, and Abilities:

　　Strong written and oral skills. Detail oriented and organized, with a high degree of accuracy and thoroughness. Excellent interpersonal skills, communication, and organizational skills. Strong judgment, decision making and trouble-shooting skills. Ability to multi-task, meet tight deadlines in a fast-paced environment. Demonstrated computer proficiency with Microsoft Office programs. Proficiency with the English Language.

　　*Standards and Expectations: *

　　Follow all Environmental Health & Safety Policies and Procedures. Work collaboratively with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives. Perform all duties within strict compliance to Patheon quality systems Standard Operating Procedures (SOPs) and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion.  Effectively engage in and adhere to departmental systems to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.). Be client and patient conscious at all times. Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving. Model positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working. Proactively identify areas for improvement in the execution of procedures. Communicate risks to timelines in an initiative-taking manner.  Consistently strives to improve skills and knowledge in related field.  

　　Physical Requirements:

　　Position 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. Use of Personal Protective equipment may be required and may include any of the following: Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.

　　Our 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.

　　Apply today! http://jobs.thermofisher.com

　　Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.