Validation Scientist Research & Development Full-time

Job Title

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life – enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.

Discover impactful work:

• Trains on routine operation, maintenance, and theory of analytical instrumentation, SOPs, and regulatory guidelines.
• Performs routine sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds with periodic direct supervision.
• Transitions to more complex techniques/procedures and performs analysis on a variety formulations and/or biological matrices throughout role tenure.
• Responsible for review and compilation of results and data comparison against SOP acceptance criteria, methodology, protocol, and product specifications.

Essential functions and other job information:

• Trains on routine operation, maintenance, and theory of analytical instrumentation, SOPs, and regulatory procedures and guidelines.
• Performs a variety of routine sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds with periodic direct supervision.
• Over time progresses to more complex techniques/procedures and performs analysis on a variety formulations and/or biological matrices.
• Completes all laboratory documentation in clear and accurate language and according to SOP and GLPs.
• Reviews and compiles results from assignments and makes initial determination on acceptability per SOP acceptance criteria.
• Problem solves with assistance pertaining to extraction and/or instrumentation problems.
• Performs work assignments accurately, and in a timely and safe manner.
• Manages QC responsibilities with minimal/no supervisor input. Communicates project status to project leader.
• Builds an understanding of QA processes and manages responsibilities with decreasing supervisor or QA input.

Job complexity and job knowledge:

Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Developing professional expertise, applies company policies and procedures to resolve a variety of issues.

Supervision received:

Receives general instructions for routine work, detailed instructions on new projects or assignments. Exercises judgment within defined procedures and practices to determine appropriate action. Consults supervisor or experienced reviewers for determining corrective actions as needed.

Business relationships:

Contacts are primarily internal to the company with infrequent external customer/vendor contact on routine matters. Builds productive internal working relationships with lab staff, functional teams and clients.

Education and experience:

Bachelor's degree or equivalent and relevant formal academic/vocational qualification. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0-2 years).

Knowledge, skills and abilities:

Knowledge of routine operation, maintenance, and theory of analytical instrumentation, SOPs, and regulatory guidelines. Knowledge of applicable regulatory authority, compendia and ICH guidelines. Demonstrates excellent manual dexterity skills, allowing for precise and accurate work. Exhibits strong written and oral communication skills, facilitating effective communication within the team and with stakeholders. Displays exceptional time management and project management skills, ensuring efficient completion of tasks. Proven problem-solving and troubleshooting abilities, enabling the identification and resolution of issues. Capable of cross-training on sample preparation techniques with another laboratory group, enhancing versatility and collaboration. Thrives in a collaborative work environment, actively contributing to a cohesive and productive team. To demonstrate behaviors which align to the 4i Values of Thermo Fisher.

Working conditions and environment:

Work is performed in a lab and/or office setting, on-site, with exposure to electrical office equipment.

Physical requirements:

Frequently stationary for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Requires multiple periods of intense concentration. Occasional crouching, stooping, bending and twisting of upper body and neck. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Ability to access and use a variety of computer software developed both in-house and off-the-shelf. Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others to obtain or relate information to diverse groups. Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. Regular and consistent attendance.

Our mission is to enable our customers to make the world healthier, cleaner and safer. 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 with PPD, part of 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.