FSP Senior Validation Engineer

at  Thermo Fisher Scientific

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.

EDUCATION AND EXPERIENCE:

• Bachelor’s degree or equivalent and relevant formal academic / vocational qualification
• AND 8+ 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

• 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