Technical Writer (Pharmaceutical Engineering Contractor)

GMP Engineering Inc.; Oakville; On-site; CAD 55,000 - 96,000; Full time

Job summary

GMP Engineering Inc. in Oakville, Ontario is seeking an independent engineering contractor to develop clear GMP-compliant controlled documentation for pharmaceutical facilities, systems, equipment and processes.

You will draft, revise and coordinate the approval of SOPs, process narratives, MEMP documentation, master batch records, and related traceability materials, collaborating with client engineering, automation, quality, validation and operations teams.

Qualifications

• Translate engineering, automation, quality and validation information into clear GMP documents.
• Working knowledge of GMP documentation, document control, and regulated pharmaceutical operations.
• Ability to manage multiple documents, priorities, review cycles, and deadlines.
• Experience within the pharmaceutical industry.

Responsibilities

• Draft and revise SOPs for process operations and automation systems.
• Create process narratives, operating descriptions, job aids, and work instructions.
• Develop Master Environmental Monitoring Plan (MEMP) documentation.
• Prepare Master batch records and manufacturing instructions.
• Produce system, equipment, and component criticality assessments.
• Assemble SQMS consumable lists and traceability documentation.

Skills

Technical writing

Editing

Documentation

Attention to detail

GMP documentation

Document control

Cross-functional collaboration

Job description

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
• System, equipment, and component criticality assessments
• 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:

• Experience within the pharmaceutical industry

LOCATION:

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