Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join our team at Thermo Fisher Scientific Inc. as an FSP-Scientific/Technical Writer and become a key player in our engineering department! This outstanding opportunity allows you to work in a world-class environment, contributing to groundbreaking advancements and ensuring flawless documentation.

Key Responsibilities:

Ensure compliance with cGMPs, SOPs, and Thermo Fisher standards of documentation to support sterile manufacturing.Coordinate the preparation of GMP/GLP documents such as Standard Operating Procedures, Production Forms, batch records, Logbooks, and Laboratory Notebooks.Support in developing metrics and key indicators for the area.Support the daily activities to ensure the manufacture of quality parenteral products for development and clinical needs.Report and maintain metrics as appropriate.

Technical Writing and Review:

Prepare, revise, and archive technical documents such as area rationales, templates, SOPs, equipment procedures, risk assessments, and contamination control strategies.Ensure zero instances of data falsification or data integrity issues.Generate and report metrics for Sterile Ops led processes.

Safety and Quality:

Inspect work area for safety regulations and recommend improvements.Implement safety, quality, and business improvements.Participate in GMP and safety self-inspection activities.

Communication and Collaboration:

Communicate proactively regarding the status of critical compliance systems and problem resolution.Lead by example, working collaboratively and embracing our company’s Code of Conduct.

Support and Training:

Provide technical support and act as a Subject Matter Expert on GQP topics.

Continuous Improvement:

Leverage continuous improvement activities to support adherence with industry regulations, Global Quality Policies, and business procedures.Lead strategies to improve the qualities and efficiencies of Sterile Ops processes and systems.Maintain a strong understanding of current technologies and professional concepts.

Additional Responsibilities:

Apply aseptic manufacturing principles to implement new technologies/processes.Apply available tools to support ongoing adherence to industry regulations and data integrity principles.Analyze and resolve diverse issues promptly, advancing when needed.Schedule and plan work to meet priorities, setting specific daily and weekly goals.Perform administrative tasks such as procedure and template revision, records filing, and archiving.Demonstrate computer proficiency, including Word and Outlook.Maintain good hygiene and hand-washing practices.Occasionally work overtime as needed.Be a committed team player, accepting a team-based culture.Identify business risks for management consideration.

Education:

Bachelor’s degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field.Minimum of 2+ years of experience providing the knowledge and skills to perform the job.Preferred understanding of GMP manufacturing.