FSP Sr. Instrument Qualification Specialist

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.

Key responsibilities:

• Manage laboratory instruments lifecycle including qualification data integrity maintenance repairs and decommissioning activities.
• Oversee instrument qualifications collaborate with instrument owners vendors and IT teams to configure systems and complete data integrity risk assessments within required timelines.
• Independently engage with instrument vendors to understand data flow software features data file generation and 21 CFR Part 11 compliance capabilities of application software.
• Prepare data integrity risk assessments configuration specifications and qualification summary reports to ensure compliance for instrument release.
• Facilitate calibration performance verification / maintenance and decommissioning activities.
• Review vendor-executed calibration maintenance repair and performance verification tasks to ensure compliance with quality standards.
• Manage schedules to ensure timely completion of qualification calibration performance verification testing and maintenance operations.
• Partner with the quality assurance (QA) team to ensure the accuracy and completeness of documentation while addressing and resolving compliance issues.
• Administer user account management activities including handling password resets and account configuration requests.
• Verify and execute data backup and restoration tasks according to defined processes.
• Ensure timely resolution of quality events to maintain compliance with procedures.
• Participate in the development update or revision of Standard Operating Procedures (SOPs).

Education and Experience:

• Bachelors degree in lab sciences such as Chemistry Biology Computer Science or similar
• Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 8 years)
• OR Masters degree and previous experience that provides the knowledge skills and abilities to perform the job (comparable 6 years)
• OR PhD and previous experience that provides the knowledge skills and abilities to perform the job (comparable 4 years)

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:

• Proficient in instrument/equipment qualification maintenance and change control processes.
• Strong experience of 21 CFR Part 11 compliance pertaining to computer systems including hardware application software and operating systems.
• Solid grasp of Data Integrity principles in a GxP environment.
• Experience in calibration maintenance and repair tasks for instrument lifecycle.
• Understanding of data file types generated by laboratory instruments and database structures.
• Demonstrated knowledge of compliance requirements under cGMP and FDA regulations including Good Documentation Practices (GDP) and laboratory GMP principles.
• Excellent attention to detail organizational skills and ability to create technical documents.
• Proven ability to work independently and collaboratively with a results-oriented mindset and the ability to drive projects to timely completion.
• Customer-focused attitude and commitment to meeting deadlines.
• Self-motivated with a proactive approach to problem-solving and task ownership.

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!