Position Summary | The Technical Writer is responsible for creating, revising, and maintaining clear, accurate, and compliant documentation to support pharmaceutical manufacturing operations. This includes standard operating procedures (SOPs), batch records, training materials, and other compliance documents. The role ensures all documentation meets Good Manufacturing Practices (GMP), FDA, EMA, and internal quality standards, and supports cross-functional teams in achieving operational excellence. Technical Writer will be responsible for authoring, reviewing, and controlling all Good Manufacturing Practice (GMP) documentation related to the transfer and scale-up of client drug products. The primary focus of this role is to translate complex technical process descriptions and engineering data into clear, concise, and compliant Master Batch Records (MBRs) for use in aseptic manufacturing operations. |
Duties and Responsibilities | - Document Creation & Maintenance: Write, edit, and maintain SOPs, batch records, and other technical documents for manufacturing and operation, based on Tech Transfer documents and process changes. Ensure the MBRs are written clearly for the end-user (Manufacturing Operators) to minimize errors and deviations.
- Regulatory Compliance: Ensure all documentation complies with GMP, FDA, EMA, and other relevant regulatory standards, as well as internal policies.
- Collaboration: Work closely with manufacturing, quality assurance, validation, safety, and engineering teams to gather technical information and ensure accuracy and clarity in documentation. Lead document review process, consolidating and incorporating feedback from Subject Matter Experts (SMEs).
- Process Improvement: Translate complex technical processes into concise, user-friendly instructions to enhance operational efficiency and reduce errors.
- Document Control: Manage document lifecycle, including version control, reviews, approvals, and archiving, using electronic document management systems (EDMS). Initiate and execute Change Control requests for all MBR and SOP updates.
- Training Support: Assist in developing training materials based on SOPs and provide support to ensure effective implementation of procedures.
- Continuous Improvement: Identify opportunities to improve documentation processes, readability, and usability, incorporating feedback from end-users.
- Other duties as assigned
|
Regulatory Responsibilities | - Conduct business in a responsible manner that complies with all state, FDA, OSHA, EPA, and DEP regulations, or otherwise as applicable
|
Supervisory Responsibilities | |
Experience | - Two plus (2 ) years of technical writing experience, preferably in pharmaceutical or sterile manufacturing environments or a CDMO.
|
Education | - Bachelor’s degree in Technical Writing, Pharmaceutical Sciences, Chemistry, Biology, Engineering, or a related field.
- Certification in Technical Writing (e.g., AMWA, STC) or GMP training is a plus
|
Knowledge, Skills & Abilities | - Exceptional technical writing and editing skills with a focus on clarity, accuracy, and conciseness.
- Demonstrated understanding of aseptic processing, cleanroom environment controls, terminology and cGMP manufacturing operations.
- Proficiency in document management systems (e.g., MasterControl) and Microsoft Office Suite.
- Ability to work collaboratively with cross-functional teams and manage multiple projects under tight deadlines.
- Knowledge of regulatory guidelines (e.g., 21 CFR Part 211, ICH Q7).
- Attention to detail, analytical thinking, and strong organizational skills.
- Exceptional verbal communication skills.
|
Physical Requirements | - Ability to meet gowning requirements.
- Ability to remain stationary for prolonged periods.
- Satisfactory audio-visual acuity.
|
