Technical Writer II
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
About the role
Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe, or helping find cures for cancer.
Thermo Fisher Scientific's Viral Vector Services (VVS) Is a rapidly growing, multifaceted gene therapy contract development and manufacturing organization (CDMO) that Is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed to making a difference in our organization, for our client partners and the patients we serve. We are looking for top talent with proven proficiencies and strong character to Join our team and help lead our organization Into the future.
Responsibilities
- Collaborates with area SMEs or technical specialist to build or revise existing procedures or documents for use in the manufacturing processes
- Acquires and verifies accuracy of technical details, manages documentation workflows and schedules and proofreads drafts for adherence to established document design and quality standards
- Performs administrative duties related to managing controlled document life cycles from issuance to Manufacturing through archival with Quality Assurance
- Maintains the GMP manual of Standard Operating Procedures and management of logbooks for the manufacturing operations
- Provides training to Junior associates on established writing standards for documentation design and quality
- Participates in initiatives to support innovation and continuous Improvement activities and improved compliance with quality procedures, policies and regulations
Requirements
- Minimum High School Diploma required with 5+ years related experience
- 3-4 years industry related experience with an Associate's Degree
- 1-2 years Industry related experience with a Bachelor's Degree
- Strong interpersonal and communications skills; written and oral
- Skill in the use of a personal computer and related software applications
- Ability to provide effective written or verbal communication to peers, senior associates and area management within their operational group
- Ability to develop logical structure for technical documents, content and illustrations
- Detail oriented while proofreading documents
- Able to recognize, understand and respond to situations requiring further evaluation and report these events (process, safety personnel, etc ) to senior specialists or area management
- Able to understand operational documents for GMP compliance, accuracy and completeness
- Gown aseptically and/or sterile gown as needed
Qualifications
- Must be able to understand operational documents for GMP compliance, accuracy and completeness
- Able to recognize, understand and respond to situations requiring further evaluation and report these events (process, safety personnel, etc ) to senior specialists or area management
- Able to develop logical structure for technical documents, content and illustrations
- Detail oriented while proofreading documents
- Must be able to provide effective written or verbal communication to peers, senior associates and area management within their operational group
- Must be able to acquire and verify accuracy of technical details, manage documentation workflows and schedules and proofread drafts for adherence to established document design and quality standards
- Must be skilled in meetings and interviews to elicit technical details from subject matter specialists
- Must be able to provide effective written or verbal communication to peers, senior associates and area management within their operational group
Skills
- Technical Writing
- Collaboration with Subject Matter Professionals
- Document Development and Management
- Quality Assurance
- Training and Development
- Documentation Design and Quality Standards
- Process Improvement
- Compliance with GMP and Safety Standards
Benefits
We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
- A choice of national medical and dental plans, and a national vision plan, including health incentive programs
- Employee assistance and family support programs, including commuter benefits and tuition reimbursement
- At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
- Retail and savings programs, such as our competitive 401(k) U.S. retirement savings plan
- Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards