Job DescriptionAs 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.Excellent Benefits PackageReview our company’s Total Rewards (https://jobs.thermofisher.com/global/en/total-rewards)Medical, Dental, & Vision benefits-effective Day 1Paid Time Off & Holidays401K Company Match up to 6%Tuition Reimbursement – eligible after 90 days!Employee Referral BonusEmployee Discount ProgramRecognition ProgramCharitable Gift MatchingCompany Paid Parental LeaveCareer Advancement OpportunitiesSummary:Reporting to the Manager, Manufacturing Validation, this role authors and implements instrument and equipment qualification and cleaning protocols.Job Functions:
Perform execution of routine equipment maintenance studies including, but not limited to system temperature/humidity mapping of Quality Control, Manufacturing, and Warehouse Storage units/areas.
Ensure Regulatory Compliance of all Quality Control temperature and humidity storage units including Stability Chambers, Incubators, and Refrigerators/Freezers.
Resolve high level issues for investigations, CAPAs, change requests, and engineering projects. Coordinate, document, and keep such according to the Patheon Quality Systems and tools.
Support day to day qualification & validation activities, including writing and execution of protocols, assembling data packs, and writing summary reports.
Will aid with the generation of lifecycle documents including P&IDs, impact assessments, criticality assessments, and quality risk assessments.
May support process validation activities including homogeneity studies, hold time studies, and development of Critical Process Parameters and Proven Acceptable Ranges (CPP/PAR).
May take part in global health authority (FDA, EMA, etc.), OSHA, EPA, 3rd party and internal audits and assessments.
Must ensure the effective and compliant use if Patheon’s Quality Systems and tools to ensure conformance to regulatory requirements and company policies.
Must keep knowledge of industry standards as applicable.
Will perform other duties as needed.
Education:Bachelor of Science degree in science, engineering, or a related field.Experience:Minimum of one year of relevant experience Direct pharmaceutical industry experience preferred.Equivalent combinations of education, training, and meaningful work experience may be considered.About Thermo Fisher ScientificOur 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 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.comThermo 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.Accessibility/Disability AccessJob Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255. Please include your contact information and specific details about your required accommodation to support you during the job application process.This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.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.