FSP Validation Analyst

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific youll 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.

This is a fully onsite role based at our customers site in New Brunswick NJ. We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position and any relocation costs will be the responsibility of the candidate.

Must be legally authorized to work in the United States without sponsorship.

Must be able to pass a comprehensive background check which includes a drug screening.

The primary focus of the System Specialist role is to work as part of a team that provides business ownership of select software systems throughout their lifecycle. These systems will support both GxP and non-GxP operations across all ASO sites. This role will collaborate with laboratory staff IT personnel and QA members to facilitate the timely delivery of lifecycle addition management of master systems data as well as end-user management of collaborative systems (i.e. SharePoint) may be required. The anticipated division is expected to be 70% system lifecycle activities and 30% management of master systems data.

Key responsibilities:

• Manage and deliver on a list of assignments with a particular focus on timeline scope and budget.
• Maintain close communication with team members to keep apprised of system status project status impact on laboratory operations and other relevant items.
• Collaborate with various cross functional colleagues (i.e. scientists instrument vendors QA and IT colleagues) to evaluate opportunities for new digital capabilities in support of continuous improvement activities setup and qualify new systems or upgrade existing systems for the ASO testing laboratories.
• Become an active participant in acquisition and divestiture activities including planning for the consolidation of duplicated systems and activities.
• For assigned systems aggregate/manage information from various sources to maintain an overall system status. This information may include roadmap/obsolesce data risk/issue lists feature requests.
• Apply FDA CFR 251 Part 11/EU Annex 11 GAMP 5 and other applicable global health authority regulations to the lifecycle of computer systems to ensure they are in a validated state supporting regulated business processes and computer software assurance.
• Follow SOPs and industry best practices.
• Author and/or review validation deliverables including requirement and design specifications summary reports pre/post executed test scripts and procedures for supported systems. Execute test scripts to prove compliance with system requirements.
• For assigned systems support operational and compliance initiatives such as periodic reviews of systems SOP updates training materials user requested enhancements and system audit trail assessments.
• Assist in the preparation of assigned systems for audit readiness.
• Facilitate audits and participate in the identification or resolution of CAPAs and other QEs.
• Develop standard operating procedures work instructions and other quality documents as needed to ensure the integrity of both the laboratory data collected and the systems used to collect the data.

Education and Experience:

• Bachelors degree in a Scientific or IT field or similar
• 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:

• Hands-on laboratory-system experience (LIMS Chromatography Data Systems or other relevant platforms) in an environment governed by GMP regulations or equivalent experience.
• Experience in acquisition/divestiture activities is a plus.
• Hands on experience managing the business configuration of collaborative tools like SharePoint particularly translating business needs into a functional design while maintaining an appropriate security posture is also a benefit.
• Excellent oral and written communication skills in addition above average competency with the Microsoft Office suite.
• Ability to perform in a highly matrixed organization structure.
• Possess expertise on Good Documentation and Good Testing Practices and solid grasp of cGMPs and Computer System Validations.
• Experience with electronic document management systems (e.g. Veeva platform SharePoint etc.) and application development and lifecycle management systems (e.g. ALM ValGenesis etc.)
• Experience with the complete system lifecycle for both regulated and non-regulated systems.
• Experience developing and delivering training for scientific software systems.

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!