26 Oct
|
GMP Engineering
|
Ontario
26 Oct
GMP Engineering
Ontario
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 explicit, 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
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📌 Technical Writer (Pharmaceutical Engineering Contractor) (Ontario)
🏢 GMP Engineering
📍 Ontario