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 clients to make the world healthier, safer, and cleaner.

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

Laboratory Computing Activities

• Authoring standard operating procedures for various systems present in BMS Manufacturing and lab environment.
• Provide support to lab systems including but not limited to Plate Readers, Cell Counters, Cell Analyzers, RT-PCR, Flow Cytometer and FCS Express.
• Reviewing and approving Laboratory systems’ Account Access Request Forms to Add, Remove or modify User access level on various systems.
• Performing System Administration by adding, modifying, or Disabling Users from System as per request.
• Performing Periodic Monitoring of GMP Laboratory computerized system by verifying Systems’ User Permissions, Configurations and Robocopy scripts, Data Backup etc.
• Investigating outcomes of Periodic Monitoring deviations or conflicts found during annual periodic Monitoring of system including review of system settings against Configuration Specifications, User List, User Permissions Robocopy Verification etc.
• Drafting Deviations for Laboratory Equipment discrepancies in Production Environment.
• Opening/initiating Change Control as change control owner and describing the need of changes to GMP environment.
• Performing Periodic Review of System Administration Procedures for Computerized Systems and deciding if the document should Keep Effective or needs revision.
• Work with Document Control Department to get System Administration SOPs reviewed, approved and effective. And performing Document Impact Analysis to verify the impact of initiation new procedure or revising existing Procedure.
• Initiating and Closing Document Change Notices within Veeva Vault while drafting a new or revising an existing SOP.
• Performing various system’s Admin audit trail reviews as a part of system’s Procedural Controls.

Promotes and provides excellent customer service and support

• Regularly reviews, prioritizes, and promptly responds to customer support requests.
• Provides technical support and guidance on computerized systems issues. Interfaces with customers to ensure all expectations are being met.

Regulatory Responsibilities

• Ensure all computerized systems remain in compliance post-production.
• Act as departmental SME in both internal and regulatory audits.

Our 4i Values:

Integrity - Innovation - Intensity - Involvement

If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application - we’d love to hear from you!

Qualifications

Education and Experience:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’) or equivalent combination of education, training, & experience.

Knowlege, Skills and Abilities:

• Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices.
• Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Biologics and clinical manufacturing.
• Ability to develop, delegate and motivate others including direct and indirect reports.
• Strong written and verbal communication skills.
• Excellent interpersonal skills with experience dealing with a diverse workforce.
• 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.
• Highly proficient computer skills in Microsoft Office Suite

Working Conditions:

Thermo Fisher 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 use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities
• Regular and consistent attendance
• As a condition of employment with PPD, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment.