Facilities & Engineering / Process Engineering Position Summary Our client is seeking a Senior Technical Writer to support the development of critical operational and compliance documentation for a newly constructed biopharmaceutical manufacturing facility. This is a high-priority initiative supporting facility startup, commissioning, qualification, operational readiness, and regulatory compliance. The successful candidate will work directly with Facilities, Engineering, Maintenance, CQV, EHS, and Operations teams to develop foundational documentation required for safe and compliant facility operations. This is a highly technical role and is not a Quality Assurance documentation position . The ideal candidate will possess extensive experience translating complex engineering and facility processes into clear, effective, and compliant documentation. Project Scope The selected consultant will support the development and completion of approximately 200+ technical documents , with additional scope anticipated as facility startup activities continue. Documentation will support operational readiness, maintenance programs, engineering systems, commissioning, qualification, and regulatory compliance efforts. Responsibilities Author, revise, and standardize technical documentation supporting Facilities and Process Engineering functions.
Develop and update:
Standard Operating Procedures (SOPs) Work Instructions (WIs) Equipment Care Procedures (ECPs) Lockout/Tagout (LOTO) Procedures Training Materials Inspection Sheets Maintenance Documentation Calibration Documentation Facilities Documentation Asset Management Procedures Change Control Documentation Collaborate with SMEs across Facilities, Engineering, CQV, Maintenance, EHS, and Operations. Gather technical information from engineering packages, vendor manuals, commissioning documentation, Procore, Veeva, and other site systems. Develop documentation supporting startup, commissioning, qualification, maintenance, calibration, and ongoing operations. Ensure documentation complies with GMP, OSHA, EHS, and facility operational requirements. Support aggressive project timelines associated with facility startup and operational readiness. Maintain consistency, traceability, and document quality across all deliverables. Documentation Areas May Include HVAC Systems Building Management Systems (BMS) Security Systems Cleanrooms Chiller Plants Boilers Electrical Infrastructure Nitrogen, Oxygen, and Carbon Dioxide Systems Compressed Air Systems Process Utilities Autoclaves Environmental Monitoring Systems Facility Equipment and Utilities Engineering and Qualification Programs Asset Management Programs Change Control Programs Maintenance and Calibration Programs Required Qualifications 8-10+ years of experience within pharmaceutical, biotechnology, or other regulated manufacturing environments. Demonstrated experience supporting Facilities, Engineering, Maintenance, Utilities, Manufacturing, or CQV organizations. Significant experience authoring SOPs, work instructions, maintenance procedures, technical manuals, and training materials. Strong understanding of GMP operations and regulatory requirements. Ability to independently gather technical information from SMEs and convert it into effective operational documentation. Excellent technical writing, communication, and organizational skills. Strong attention to detail and ability to manage multiple deliverables simultaneously. Preferred Qualifications Experience supporting greenfield facilities, startup operations, commissioning, or qualification projects. Familiarity with Veeva, Procore, CMMS platforms, VelocityEHS, EMS, or similar systems. Experience within biologics, cell therapy, gene therapy, vaccine, or advanced therapeutics manufacturing. Engineering, Facilities, or other technical operations background.
