Job Abstract

Work Schedule

Environmental Conditions

Job Description

Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner.
 

Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to demonstrate 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.

A Day in the Life:

• Experience with laboratory instrument/equipment qualification, vendor protocol preapproval, periodic calibration, performance verification, preventive maintenance, change control, decommissioning and documentation archival

• Reviews and approves vendor performed calibration, maintenance, repair, and performance verification records for accuracy, completeness and compliance to client standards

• Completes equipment calibration, preventative maintenance, performance verification and repair functions

• Writes and support deviations and investigations that result from calibration or performance verification failures along with developing and supporting the implementation of corrective and preventative actions

• Working closely with instrument owner to setup the system in assigned timelines

• Collaborate with the quality unit to ensure completeness and accuracy of submitted documentation, as well as addressing/resolving compliance concerns to GMP regulatory standards

• Support the development, revision and review of written procedures for calibration, preventative maintenance and performance verification of equipment

• Regularly reviews, prioritizes and promptly responds to customer equipment performance verification and support requests.

• Provides technical support and guidance on calibration, equipment performance verification and validations issues. Collaborate with customers to ensure all expectations are being met

• Maintains a positive relationship with all the members of the GMP Laboratory Systems and site customers while promoting a positive team environment

• Management of user accounts, password reset etc., as requested by users

• Participation in preparation of standard operating procedures

• May help with data integrity support

Education and Experience:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification

• AND 6+ years of previous experience that provides the knowledge, skills, and abilities to perform the job or equivalent combination of education, training, & experience.

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:

• Experience and understanding of cGMP, GXP, GDP, SDLC regulations, including 21 CFR Part 11 compliance for computer system (hardware, application software and operating system)

• Experience with laboratory instrument/equipment qualification, Re-Qualification, Validation, deviation and change control process.

• Advance knowledge of pharmaceutical, laboratory and manufacturing systems and equipment

• Highly proficient computer skills in Microsoft Office Suite-Word, Excel, PowerPoint and Outlook with extensive background in database systems. Innate ability to learn new software

• Strong written and verbal communication skills

• Ability to interact effectively with laboratory, QA and Facilities group

• Strong multi-tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks/assignments with others that may impact timely completion.

• Ability to effectively manage multiple tasks and activities simultaneously

• Ability to create documents using existing document templates

• Possess firm understanding of data file types generated by laboratory instruments including database structure

• Demonstrated understanding of compliance, cGMP and FDA requirements including Good Documentation Practices (GDP) as well as laboratory GMP principles (21CFR Part 210 / Part 211)

• Must be detailed oriented, well organized with excellent communication and technical writing skills

• Capable of working both independently as well as in the team, driving projects to completion with minimal oversight

• Must have customer focused attitude and able to meet the assigned timelines

• Must have ability to interact and accurately communicate the information with appropriate team members, co-workers and supervisor

• Must be self-motivated and driven to move the project to completion

Work Environment:

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. 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!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. 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.

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

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

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.