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Job Description
Description
Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.
Your Role:
The Sr. Technical Writer, Manufacturing plays a critical, execution-focused role within Manufacturing, responsible for authoring, revising, and maintaining clear, compliant, and operator-friendly GMP documentation. This role works directly with Manufacturing Subject Matter Experts (SMEs) on the production floor to translate actual manufacturing practices into effective SOPs and controlled documents that are both regulatory-compliant and practical for day-to-day execution. The Manufacturing Sr. Technical Writer partners closely with Quality while remaining Manufacturing-owned, ensuring documentation accurately reflects how work is performed across Formulation, Upstream, and Downstream operations.
Key Responsibilities:
- Author, revise, and maintain Manufacturing SOPs, work instructions, forms, and related controlled documents in alignment with GMP requirements.
- Work side-by-side with Manufacturing SMEs on the floor to observe operations and accurately document process execution.
- Translate real-world manufacturing practices into clear, compliant, and usable procedures that support right-first-time execution.
- Support Manufacturing-owned documentation for deviations, CAPAs, and change controls, including drafting and revising manufacturing sections.
- Partner with SMEs to ensure investigations, CAPAs, and Change Controls accurately reflect manufacturing execution and root cause.
- Coordinate document review, approval, and revision workflows through electronic document management systems.
- Ensure timely updates to GMP documentation in response to process changes, continuous improvement activities, and audit findings.
- Support Manufacturing during client audits and regulatory inspections by assisting with document presentation, remediation, and follow-up updates.
- Maintain document lifecycle management, including periodic review, version control, and archival in accordance with company procedures.
- Manage multiple documentation projects simultaneously while meeting deadlines and manufacturing priorities.
- Collaborate cross-functionally with Quality, MSAT, Engineering, and Operations to ensure documentation alignment.
- This role is highly execution-focused and requires regular presence in manufacturing areas to support documentation accuracy and usability. The Manufacturing Technical Writer is expected to be responsive to operational needs, demonstrate strong ownership of deliverables, and provide disciplined documentation support that enables safe, compliant, and efficient manufacturing operations.
Minimum Qualifications:
- Bachelor’s degree in a scientific, engineering, or related discipline, or equivalent industry experience.
- 5+ years of GMP technical writing experience within biologics, pharmaceutical, or regulated manufacturing environments.
- Hands-on experience authoring and revising SOPs, deviations, CAPAs, and change controls from a manufacturing perspective.
- Strong understanding of biologics manufacturing operations, including Formulation, Upstream, and Downstream processes.
- Proven ability to work directly with manufacturing personnel and SMEs to capture accurate process details.
- Strong knowledge of FDA GMP regulations and documentation best practices.
- Experience using electronic document management systems (e.g., Veeva, TrackWise).
- Excellent written and verbal communication skills with a strong attention to detail.
- Ability to balance compliance requirements with practical, operator-focused documentation.
Position Type/Expected Hours of Work:
This role is a full-time onsite position. Days and hours of work are Monday through Friday, 8:00am to 5:00pm PST unless otherwise stated by Supervisor. The employee must also have the ability to work overtime and/or weekends when necessary.
Compensation:
We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
The compensation range for this role is $ $88,000 - $99,900 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.
Who you are:
- You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
- Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
- You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
- You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment:
In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.