Systems Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

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.

Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical / biopharmaceutical company, all while maintaining full-time benefits.

Key responsibilities :

This position is a technical support role within the Lab Digital Sciences organization QC Digital System Technical Support pillar that is responsible for building and maintaining LIMS master data, following developed standards in direct support of Global Quality Control Operations that are responsible for testing to support new product introductions, site manufacturing plans, global stability programs, analytical method technical transfer and other non-routine testing activities. This position will ensure compliance with established procedures, methods, specifications, sampling plans, and data reporting requirements that include, and may not be limited to, raw material, water, microbial, biologics drug substance and / or biologics drug product testing, while additionally providing ad hoc technical support to QC labs users to ensure operational and business needs are addressed to ensure timely completion of product release and stability testing to ensure supply of medicines to our patients.

Create and maintain master data / static data in lab digital systems by following established standards and performing the appropriate change management process to support laboratory testing activities.

Implement and document appropriate change control associated with the Enterprise system application, which requires knowledge of system interfaces and impact to each other. Collaborate with more experienced team members as needed to understand system interfaces.

Collaborate with appropriate laboratory personnel to ensure laboratory needs and requirements are accurate in the lab system setup.

Test changes / enhancements through dry runs and receive feedback from lab users, when required.

Implement User Acceptance Testing (UAT) for system functionality changes.

Contribute to implementing lab system improvements to enhance compliance and the efficiency of laboratory operations (i.e. testing queues, testing metrics monitoring, etc.).to support product release, new products, key performance indicators / lean lab metrics.

Maintain up to date knowledge on functionality and apply knowledge to enhance site use of the system to ensure efficient operations.

Provide ad hoc support to users for issues / questions on the system.

Author, revise, and / or review procedural documents, such as SOPs and WIs and contribute to the development of associated training content.

Assist with integration and training of users and less experienced staff on use of the lab systems.

Communicate technical issues and activity status updates to team members / direct management.

Education and Experience :

Systems Developer II - Bachelor's degree in relevant scientific, life sciences, computer, or engineering or similar and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3 years’)

OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years’)

Systems Developer - Bachelor's degree in relevant scientific, life sciences, computer, or engineering or similar and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years’)

OR Masters degree

In some cases, an equivalency, consisting of a combination of appropriate education, training and / or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities :

Basic knowledge and understanding of analytical techniques preferred.

Basic knowledge in at least one lab system (LIMS, LES, Empower, MODA, CIMS, etc.) or has knowledge of systems / databases / programming.

Basic knowledge of databases and / or Microsoft Office Applications (Access, Excel, Project, PowerPoint, SharePoint, Teams, Word) and / or other relevant software programs, preferred.

Ability to interpret and apply cGMPs, regulatory requirements, and industry standard methodologies.

Interpersonal, oral, and written communication skills are needed. Must contribute to a team based, collaborative and positive environment, clarity of purpose and high commitment to business goals.

Proven problem solving ability, attention to detail, and analytical thinking skills.

Ability to take initiative and prioritize objectives from multiple projects; adhere to scheduled timelines while maintaining flexibility, independently or as part of a team.

Ability to receive and act on assignments that do have a clearly defined process.

Ability to work independently or as part of a team.

Must be flexible to adjust workload to adapt to changing business needs.

Working Environment :

Below is listed the working environment / requirements for this role :

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary and / or standing for typical working hours.

Able to lift and move objects up to 25 pounds

Able to work in non-traditional work environments.

Able to use and learn standard office equipment and technology with

proficiency.

May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

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.