FSP-Scientific/ Technical Writer

Work Schedule

Environmental Conditions

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.