Technical Writer (Pharmaceutical Engineering Contractor)

We are a specialized engineering company with international exposure and subject matter expertise in the design, fabrication and qualification of sterile, high purity and potent containment process equipment and plants. We are growing our company size and capabilities through recruitment of talented professionals. We offer a true creative engineering design work environment with a wide range of interesting projects in the bio-pharmaceutical, personal care and food industry.

POSITION:

We are seeking an independent engineering contractor to develop clear, accurate, GMP-compliant controlled documentation for pharmaceutical facilities, systems, equipment, and processes in collaboration with client engineering, automation, quality, validation, and operations teams.

SUMMARY:

Working with project and site stakeholders, you will be responsible for drafting, revising, and coordinating the approval of:

• Standard Operating Procedures (SOPs) for process operations and automation systems
• Process narratives, operating descriptions, job aids, and work instructions
• Master Environmental Monitoring Plan (MEMP) documentation
• Master batch records and associated manufacturing instructions
• Industrial hygiene (IH) test plans
• System, equipment, and component criticality assessments
• Validation Master Plans (VMPs), including cleaning VMPs
• Supplier Quality Management System (SQMS) consumable lists
• Production consumable lists, mappings, and related traceability documentation

SKILLS:

• Strong technical writing, editing, organization, and attention to detail, with the ability to translate engineering, automation, quality, and validation information into clear user-focused documents.
• Working knowledge of GMP documentation, document control, and regulated pharmaceutical operations.
• Effective collaboration with subject matter experts and cross-functional reviewers; able to independently manage multiple documents, priorities, review cycles, and deadlines.

QUALIFICATIONS:

• Bachelor’s degree in engineering
• Experience within the pharmaceutical industry

LOCATION:

• The primary work location will be our Oakville, Ontario office