Requisition Title: Senior Technical Writer
Requisition ID: 160773BR
When you're part of the team at Thermo Fisher Scientific, you will do important work, like helping customers in finding cures for cancer, protecting the environment, or making sure our food is safe. Your work will have real-world impact and supported in achieving your career goals.
Location/Division Cambridge, MA Pharma Services Division
How will you make an impact?
The Senior Technical Writer reports into the Viral Vector Services group at Thermo Fisher Scientific and is based in the Cambridge, MA office. The Sr Technical Writer in this role will be part of a cohesive team responsible for Deviations, CAPAs, and Change Controls for all phases of manufacturing. The Sr Technical Writer uses expert knowledge of cGMP regulations and project management to ensure manufacturing readiness. The incumbent will also support equipment, documentation, investigations, and improvement initiatives within the manufacturing operations. Works independently with minimal supervision and direction. Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion.
What will you do?
- Support manufacturing at tech transfer with change controls if needed.
- Support manufacturing corrective and preventative actions
- Support manufacturing internal and external observations
- Lead manufacturing investigations if needed.
- Support daily huddle meetings if needed.
- Practices and promotes safe work habits and adheres to safety procedures and guidelines.
- Utilizes manufacturing process knowledge and investigational skills to identify and resolve manufacturing issues and drive continuous improvement in process operations.
- Maintain and Improve Systems:
- Performs training with staff for Deviations, Change Controls, and CAPAs as needed
- Supports cross-functional continuous improvement teams, with Engineering, Validation, Quality Assurance, Quality Control, Facilities, and Manufacturing Science and Technology
- Supports cross-functional company goals for Site Metrics.
- Builds cross-functional relationships and enhances relationships with team members.
- Works cooperatively with others to meet group and organizational goals.
- Participates in initiatives to support, innovation and continuous improvement activities and improved compliance with quality procedures, policies, and regulations.
- Participate in client and planning meetings as requested.
Bachelors' Degree preferred
- Minimum of 7 years' experience in pharmaceuticals manufacturing and/or quality
- Demonstrated ability to motivate exempt and non-exempt employees and demonstrated management skills, (i.e., business knowledge, leadership, communication, ability to analyze technical issues, conflict resolution).
- Thorough knowledge of cGMPs
- Strong interpersonal and communications skills; written and oral
- Ability to function in a fast paced, dynamic environment with multiple priorities simultaneously.
- Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
- Ability to make decisions and work with minimal to moderate supervision.
- Able to provide effective written or verbal communication to peers, senior associates, and area management within their operational groups.
- Strong planning, organization, and multitasking skills
- Solid understanding of root cause analysis tools
- Strong Leadership skills
At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
To Apply, please click the following link: https://thermofisher.contacthr.com/83836209
Apply on company website