Technical Writer *PC 1557

This position is in the Manufacturing Science and Technology team (MS&T) team at Miltenyi Biotec, Gaithersburg MD site. We are seeking a detail-oriented and experienced Technical Writer to join our team. In this role, you will be responsible for creating, editing, and maintaining high-quality documentation in support of regulatory submissions, manufacturing processes, quality assurance, and development activities.

This position requires a strong understanding of regulations, scientific/technical terminology, and the ability to communicate complex information clearly and accurately to a range of audiences. This role is responsible for creating technical reports, templates and manuals, explaining complex information in a clear and concise manner and working with technical staff to ensure accuracy of descriptions.

Essential Duties and Responsibilities:

1. Draft and edit documentation:Write and revise a wide range of documents according to regulatory and company standards.




• Standard Operating Procedures (SOPs):Detailed instructions for performing routine operations.
• Batch records:Records detailing the manufacturing process of a specific product batch.
• Protocols and reports:Documents for clinical trials, validation studies, and investigations.
• Regulatory submissions:Documents submitted to regulatory authorities like the FDA and EMA for drug approval (e.g., INDs, NDAs).




2. Collaborate with subject matter experts (SMEs):Work with scientists, engineers, quality assurance, and manufacturing staff to gather information and ensure technical accuracy.
3. Investigate and document quality events:Investigate non-conformances (NCRs), deviations, and root causes, then document the findings and the resulting corrective and preventive actions (CAPAs).
4. Manage document control:Handle documentation throughout its lifecycle, including version control, revisions, and archival, often using an electronic document management system (EDMS).
5. Ensure regulatory compliance:Maintain deep knowledge of and adhere to regulations such as current Good Manufacturing Practices (cGMP), FDA guidelines, and International Council for Harmonization (ICH) guidelines.
6. Adapt content for different audiences:Tailor writing for multiple audiences, including regulatory agencies, healthcare professionals, and patients.
7. Contribute to process improvement:Analyze and evaluate existing documentation and processes to identify and implement opportunities for enhancement.

Requirements:

• Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Technical Communication, or a related field; 3+ years of technical writing experience in a regulated pharmaceutical, biotech, or life sciences environment.
• Strong knowledge of FDA and ICH guidelines, GMP/GLP documentation standards.
• Excellent written and verbal communication skills.
• Proficient in Microsoft Office Suite and document management systems.
• Understanding of biopharmaceutical processes used to manufacture therapeutics (cell culture, harvest, chromatography purification steps, etc.); viral vectors highly preferred.
• Detail oriented with the ability to organize large amounts of data for clear presentation.

Skills:

• Skillful in writing sophisticated processes in an informational and explanatory style.
• Know-how of process improvement and procedural documentation rules.
• Good problem-solving skills.
• Collaboration and team-working skills.
• Understand industry trends in technical communication, information architecture, and content development.

Physical Demands:

• Good eye/hand coordination
• Use keyboard/computer/phone

Work Environment:

• Regular and predictable attendance

The hiring range for this position is expected to fall between $32.64 - $38.38/hour, reflecting the range candidates can reasonably expect to be considered for at time of offer, based on factors such as experience, internal equity, and qualifications.

The salary of the finalist(s) selected for this role will be set based on a variety of considerations, including but not limited to internal equity, experience, education, specialization, skills, abilities, and training. The above range represents the Company's good faith and reasonable estimate of possible compensation at the time of posting.

In addition to your salary, the Company offers a comprehensive benefits package, including health, vision, and dental insurance, as well as a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions may also be eligible for additional compensation such as bonuses or commissions.

Miltenyi Biotec is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

Miltenyi Biotec, Inc. participates in E-Verify.

Are you ready to start revolutionizing biomedical research? When you join Miltenyi Biotec, you join a family that is passionate about making a real impact - one breakthrough at a time. One integral division of that Miltenyi Biotec family is Miltenyi Bioindustry - our contract development and manufacturing organization (CDMO). As a full-scale CDMO, we provide customers with services for the development and manufacturing of lentiviral vectors and cell and gene therapy products. This crucial arm of our enterprise bridges the gap between research and mass bioproduction, ensuring that our solutions are accessible on a global scale. Miltenyi Bioindustry plays a unique role as both the producer and the service provider, relying on our instruments and reagents for each workflow step, controlling the entire supply chain and thus delivering greater security and planning clarity to our customers.