Senior Validation Engineer

7 days ago

Allentown, United States Thermo Fisher Scientific Full time

Work Schedule Standard (Mon-Fri) Environmental Conditions Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) 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. Location/Division Specific Information CTD partners with pharmaceutical and biotech customers around the world to ensure the right patients get the right therapies in the right doses at the right time – a concept that we internally embrace as “There is a Patient Waiting.” Our unique blend of services includes project management, packaging, distribution, transportation management and specialty logistics, ancillary supply management, clinical supply optimization, bio-repository storage and much more. Our more than 3,500 employees in over 15 countries work hard every day knowing that what they do matters. Discover Impactful Work: As part of our distributed team, what you do gives directly to our mission; enabling our customers to make the world healthier, cleaner and safer. A day in the Life: As a Senior Validation Engineer, you will collaborate with multiple departments to support the validation of computer systems, equipment, processes, utilities, and facilities necessary for packaging operations at the site. Your role will involve ensuring site compliance and timely execution of essential activities to maintain the validation of all GxP systems. Responsibilities Lead and further develop the Validation and Technical Services Department Responsible for the preparation, execution, and eventual review and approval of documentation (SIA, URS, RA, FAT, SAT, VP, IQ, OQ, PQ, TM, PPQ) as well as the generation of corresponding summary report Achieve and maintain a level of Validation expertise for all systems and processes at the site in order to coach and mentor junior validation engineers Continuously look for means to optimize processes to improve compliance and efficiency. Lead meetings and participate in other discussions to acquire agreement on Validation approaches. Conduct all work according to governing SOPs and cGMPs (current Good Manufacturing Practices). Coordinate Validation Projects and ensure project timelines Drive maintenance of the Validation Master Plan (VMP) as needed Demonstrates and promotes the company vision of the 4 I’s: Integrity, Intensity, Innovation, and involvement Author SOPs related to validation/revalidation activities Demonstrate sound decision making related to priorities Conducts all activities in a safe and efficient manner Keys to Success: Education Bachelor degree from an accredited college or university, preferably in Engineering or a Science-based subject. Experience 5+ years of validation experience in a regulated industry. Pharma engineering experience Experience with regulatory requirements as applied to the qualification and management of Controlled Temperature Unit (CTU) Operation Knowledge and experience with IQ’s PQ’s & OQ’s with GMP experience Knowledge of the lifecycle of Validation documentation is required PC literacy including the ability to generate documents in both Microsoft Excel and Microsoft Word Must be prepared to provide direction and leadership to team and external functions and activities Must exhibit Interpersonal skills; analytical skills; ability with multitasking/shifting priorities Be results oriented Physical Requirements Be able to lift 35 pounds BENEFITS: We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation. 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.

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