Technical Writer Ii

Job Description
When you're part of the team at Thermo Fisher Scientific, you'll 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 you'll be supported in achieving your career goals.
Location/Division Specific Information
Work Location: Cambridge, MA
At Viral Vector Services (VVS), a division of Thermo Fisher Scientific, we manufacture the latest viral vector therapies. We offer the expertise and resources necessary to help clients bring their drug discoveries from process development though clinical supply and commercial manufacturing. VVS is located at the forefront of ThermoFisher's leading and groundbreaking Cell and Gene Therapy business, enabling clients to cure genetic, rare, and otherwise untreatable diseases.
How will you make an impact?
The Technical Writer II reports into the Viral Vector Services group at Thermo Fisher Scientific and is based in the Cambridge, MA office. The Technical Writer II uses expert knowledge of cGMP regulations and project management teams to ensure manufacturing readiness. The Technical Writer II will also support documentation, investigations and improvement initiatives within the manufacturing operations.
What will you do?

• Lead, create, maintain and implement effective corrective and preventative actions (CAPAs)
• Attend Root cause meetings to build effective CAPAs
• Support manufacturing at acquiring required documentations for Major deviations (Record scanning)
• Works independently with minimal supervision and direction
• Support manufacturing CAPAs including document revision implementations
• Lead manufacturing investigations
• Practices and promotes safe work habits and adheres to safety procedures and guidelines
• Applies manufacturing process knowledge and investigational skills to identify and resolve manufacturing issues and drive continuous improvement in process operations
• Builds cross-functional relationships and enhance relationships with team members
• Works collaboratively with subject matter authorities to meet group and organizational goals
• Proactive identification and mitigation of risks
• Identification of process changes and improvements
• Support daily huddle meetings if needed.

How will you get here?
Education

• High school diploma or GED equivalency.
• Bachelor's Degree preferred.

Experience

• Minimum of 0-2 years' experience in pharmaceuticals manufacturing and/or quality.
• Experience with Trackwise preferred.
• Detailed knowledge of cGMPs.
• Solid understanding of root cause analysis tools.
• Proven track record to empower exempt and non-exempt employees and demonstrated management skills, (i.e., business knowledge, leadership, communication, ability to analyze technical issues, conflict resolution).

Knowledge, Skills and Abilities

• 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 optimally 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.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.