Curia Technical Writer in Hopkinton, Massachusetts
Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.
Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.
Creates manufacturing Batch records and supportive documents, both in paper and electronic format. Writes, and edits technical documents related to bio-manufacturing by working with cross functional teams. Has advanced Microsoft Word and computer literacy skills to creating efficient, accurate documents while remaining compliant with the regulatory requirements. Sets priorities to ensure documents are ready when needed per the production schedule. Be a leader in implementing electronic batch records at the site.
Essential Duties and Responsibilities:
Creates or revises and manages the workflow for MFG documents
Determines reviewers/ approvers based upon the changes requested and the document type
Obtains technical content from Subject Matter Experts (SMEs) including Bill of Materials, Equipment list, Process Parameters
Drafts new / revises existing documents using current templates
Follows up with the reviewers/ approvers and address comments
Coordinates the document workflow
Work with end users to ensure document has appropriate prompts/space to fill in required execution information
Ensures accurate references within document and to other documents
Continuous improvement of batch record templates based on feedback from MFG operations, QA and other stakeholders
Facilitates meetings to resolve / address comments (if the document revision is extensive), and to reach consensus with multiple stakeholders
Authors manufacturing summary documents for clients
Minimum two (2) year work experience in GMP regulated industry; Associates/Bachelor’s degree or biotechnology vocational training from an accredited institution preferred.
Knowledge of Biologics with bio-manufacturing and documentation management system processes experience.
Advanced proficiency in MS Word and computer literacy.
Technical writing experience of one (1) year with a certificate in Technical writing is highly desirable.
Quick learner, understanding of presented technical/scientific content.
Ability to write clearly, concisely, accurately, and quickly under tight deadlines.
Keen attention to detail and high regard for quality.
Experience working in a self-driven, performance/results oriented, fast paced environment.
Must be highly collaborative and can work within a diverse team and contribute to a supportive, positive work environment both within the team and in the greater community.
Bio-manufacturing floor operations, training, validation, quality assurance experience in a bio-pharmaceutical industry is highly desirable.
U.S. employees of Curia Global Inc. and its subsidiaries (a “Company”) hired after December 7, 2021 must be fully vaccinated against the COVID-19 virus and provide the Company with proof of vaccination as a condition of their employment except for U.S. employees who request and qualify under applicable law for disability and religious accommodations from the COVID-19 vaccine mandate. An applicant who receives an offer of employment from the Company for a position as a U.S. employee will be required to provide proof of vaccination, or to request and receive a disability or religious accommodation that the applicant is entitled to under applicable law, before their first day of employment or any earlier or later deadline specified by the Company in the offer letter. The Company is an equal opportunity employer and provides employment opportunities and makes employment decisions without regards to an individual’s disability or religion or on any other basis prohibited by applicable law.
All interested applicants must apply online. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
- Curia Jobs