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!

This growth role is available in Manufacturing Science & Technology’s (MSAT’s) Process Validation department at Thermo Fisher Scientific.

Qualified individuals will lead process validation activities for customer programs and will be responsible for planning and executing process validation studies in support of PPQ batches and commercial process optimizations. This role will be primarily responsible for authoring process validation protocols, overseeing study execution, analyzing the findings, and creating written reports summarizing the findings. This role will require cross-functional work with QA, operations, quality control and process engineering to ensure validation studies are performed appropriately according to site policies and regulations.

This person has a core competency in process validation and experience with either upstream (cell culture) or downstream (protein purification) processes as well as experience working with single-use technology.

Key Responsibilities:

Provide technical direction to core teams and act as customer-facing lead for project teams

Manage the scope, schedule, and reporting of PV program activities for individual products and/or clients; ensure status, risks, and open issues are tracked and that all stakeholders are informed of changes.

Design PV studies to meet the stated intent including development of acceptance criteria.

Author and review PV Plans and protocols.

Review data to ensure accuracy and completeness. Effectively trend and chart data for process validation reports.

Author and perform the technical review of deviations and change controls related to commercial manufacturing.

Identify potential root causes of variation and deviations using a systematic approach. Expertise in use / application of variety of problem-solving tools e.g. Ishikawa, Kepner-Tregoe (KT), five-whys, etc. Resolve complex problems and lead multidisciplinary teams in developing and implementing solutions.

Collaborate with global PV team to drive strategy alignment across the greater network.

Education

Bachelor or Master’s degree required in Engineering, Biochemistry or Biology. Other engineering or science degrees considered based on relevant work experience.

Minimum Requirements

4+ years of process validation experience and/or experience in fields related to biologics drug manufacturing. Commercial scale manufacturing experience is required. Diverse knowledge and experience in relevant areas is preferred.

Strong understanding of current global regulations related to process validation and understanding of the applications. Experience with regulatory inspections is a plus.

Knowledge of Good Manufacturing Practices and statistical methods used for Pharmaceutical Process Analysis.

We offer competitive salary, an annual incentive bonus plan, 401K with company match up to 6%, tuition reimbursement and a range of other employee benefits! We foster an exciting company culture that encourages innovation, forward-thinking, and an outstanding career and development prospects. Come be a part of the team!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. 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.

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

Preferred language: English

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: We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.