Technical Writer / Manufacturing SOP Specialist (Biotech Drug Substance Operations)

We are seeking experienced Technical Writers / Manufacturing SOP Specialists to support a major initiative within a Biotech Drug Substance Manufacturing Operation in Barceloneta, Puerto Rico. The selected resources will be responsible for the review, revision, optimization, and standardization of manufacturing Standard Operating Procedures (SOPs) and related controlled documentation to support operational excellence, compliance, and process efficiency initiatives at the client site. This is a fully onsite role requiring hands-on collaboration with Manufacturing, Process Engineering, Quality, Validation, and Operations personnel.

• →Review existing manufacturing SOPs, batch records, and operational documentation for accuracy, clarity, compliance, and efficiency
• →Update and optimize procedural documentation in alignment with current manufacturing practices and regulatory requirements
• →Collaborate with Subject Matter Experts (SMEs) across Manufacturing, Quality, Engineering, and Compliance departments
• →Identify opportunities for process simplification and procedural improvements
• →Ensure documentation complies with GMP, FDA, and internal quality standards
• →Support document lifecycle activities including routing, review coordination, version control, and approvals
• →Participate in onsite meetings, walkthroughs, and process observations to capture operational requirements accurately
• →Maintain consistency in formatting, terminology, and technical writing standards across documentation packages

• Bachelor’s degree in science, Engineering, Technical Writing, or related field preferred
• Minimum of 3–5 years of experience in biotech, pharmaceutical, or regulated manufacturing environments
• Strong experience reviewing and authoring manufacturing SOPs and controlled GMP documentation
• Experience supporting Drug Substance manufacturing operations highly preferred
• Strong technical writing, editing, and document management skills
• Familiarity with GMP regulations, FDA compliance expectations, and documentation practices
• Ability to interact effectively with cross-functional teams and manufacturing personnel
• Strong attention to detail and organizational skills
• Ability to work independently in a fast-paced manufacturing environment

• Biologics or biotech manufacturing experience
• Experience with document management systems (Veeva, TrackWise, MasterControl, etc.)
• Previous experience supporting remediation, optimization, or continuous improvement initiatives
• Bilingual (English/Spanish) preferred

• Fully onsite position in Barceloneta, Puerto Rico
• Manufacturing and operational support environment

• Candidates must have prior experience supporting similar manufacturing operations and demonstrated expertise in technical writing within regulated biotech or pharmaceutical environments.