Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, 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 will 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.

Discover Impactful Work:

As a Senior Manager, Deviation Management, you will lead a highly skilled team responsible for implementing innovative digital processes to ensure successful delivery of deviation investigations and recommendations to prevent deviation re-occurrence.

A day in the Life:Develop working relationships with counterparts in other areas supporting aseptic manufacturing, testing, planning, and release and is required to apply sound scientific principles to investigate process deviations.Lead a team responsible for investigation of deviations and project timelines that ensure key compliance and customer due dates are met; raising any potential misses and develop remediation plans.Prepare source documentation for regulatory filings, supporting and supporting requests for regulatory inspections related to process overviews, investigations, projects, and validation.Domain Expert (SME) for the Deviation Management team. With in-depth expertise, support and perform deviation investigations that strive to prevent deviation re-occurrence. Determine root cause, identify corrective/preventative actions, event scope, and conduct a product impact assessment.Focus on enhancing adoption of digitization in deviation management: efficiency and automation, enhanced reporting and compliance, centralized dataCollaborate with various departments to gather information, evaluate causal factors, and implement corrective and preventive actions (CAPAs)Provide timely written documentation of investigations and communicate recommendations based on investigation outcomesWork with your team to collect and analyze relevant data to identify patterns, trends, or potential causes and communicate recommendations based on outcomesEstablish a culture of thorough documentation, ensuring accurate recording of all relevant informationKeys to Success:Set high standards of performance for self and others; assuming responsibility and accountability for successfully completing assignments or tasks; self-imposing standards of excellence rather than having standards imposedLead projects that improve the performance of our processes, including projects focused on Right-First-Time performance or preventing/reducing deviations. Question current practices or conventional thinking by suggesting alternative approaches and creative solutionsEducation:Bachelor's degree in mechanical or chemical engineering or similar science degreeExperience:Experience in support of Production, Process Engineering, Validation, or related experience. Experience in a regulated environment, preferably in biologics or pharmaceuticalsMinimum 2 years of deviation managementExperience developing a successful team, instruction, and mentorship to help others excel in their current or future jobsExperience with CAPA, quality assurance, root cause analysis, deviations, and pharmaceutical industry standardsKnowledge of GMP and FDA regulationsProficiency in technical writing and quality processesExperience with Six Sigma methodologiesKnowledge, Skills, Abilities: Evaluate data and make recommendations driven by trend analysisAbility to work effectively in a fast-paced environment and prioritize tasksAnalyze metrics to assess progress against objectivesConvey technical concepts accurately and clearlyPhysical Requirements / Work Environment:Good Manufacturing Practices (GMP) Safety StandardsSome degree of PPE (Personal Protective Equipment)Benefits:

We offer competitive compensation, 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!

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 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.

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.

Accessibility/Disability Access:

Job 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 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.