MSAT Technical Writer

Lonza•Tampa, FL

About The Position

Join our Manufacturing Sciences and Technology (MSAT) team and play a key role in supporting the production of high‑quality solid oral dosage (OSD) medicines. In this role, you will contribute directly to compliant, efficient, and reliable pharmaceutical manufacturing by developing and maintaining Master Batch Records (MBRs) that ensure process accuracy and regulatory compliance. What you will get: A competitive compensation. In addition, below you will find a comprehensive summary of the benefits package we offer: Performance-related bonus. Medical, dental and vision insurance. 401(k) matching plan. Life insurance, as well as short-term and long-term disability insurance. Employee assistance programs. Paid time off (PTO). Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.

Requirements

Bachelor’s degree in Life Sciences or a related field.
Proficient experience in a cGMP pharmaceutical environment, strongly preferred within OSD manufacturing, QA, or documentation control.
Proven ability to author clear, accurate, and compliant technical documentation.
Strong understanding of cGMP requirements and regulatory expectations.
Proficiency in Microsoft Word and general MS Office tools.
Strong attention to detail, organization, and ability to collaborate with cross‑functional technical teams.
Ability to adapt documentation based on process changes, data, and continuous improvement initiatives.

Responsibilities

Create, edit, and format Master Batch Records (MBRs) for all OSD manufacturing stages, including dispensing, blending, granulation, compression, encapsulation, coating, printing and packaging
Incorporate in‑process controls (IPCs), critical process parameters (CPPs), and yield calculations into compliant documentation.
Maintain standard templates and provide training to supporting groups as needed.
Ensure documentation complies with cGMP, FDA, EU guidelines, Good Documentation Practices (GDP), and internal formatting standards.
Revise MBRs to reflect approved change controls, CAPAs, and process or workflow optimizations.
Collaborate closely with MSAT Engineers, Formulation Scientists, and Production Supervisors to ensure technical accuracy and alignment with manufacturing processes.
Suggest and implement continuous improvements to streamline documentation workflows and reduce errors while upholding all Safety and Sustainability expectations.