Publié il y a 22 jours
Technical Writer (Pharmaceutical Engineering Contractor)
@ GMP Engineering Inc.
Oakville, Ontario
En bref
GMP Engineering Inc. is hiring an independent technical writer contractor to draft and maintain GMP-compliant controlled documentation for pharmaceutical facilities and processes. The work covers SOPs, batch records, validation master plans and related documents, done with client engineering, quality and validation teams. Full-time, primarily at the Oakville, Ontario office.
Responsabilités :
- Draft and revise SOPs and process narratives
- Prepare master batch records and environmental monitoring plans
- Write validation master plans, including cleaning VMPs
- Maintain consumable lists and traceability documentation
- Coordinate document review and approval with stakeholders
Résumé des exigences :
- Bachelor's degree in engineering
- Experience in the pharmaceutical industry
- Working knowledge of GMP documentation and document control
- Strong technical writing and editing skills
- Ability to manage multiple documents and review cycles
Source et dates
Type de source non vérifié · apify-linkedin
- Date publiée par l’employeur
- 2026-10-19
- Première détection par notre source
- 2026-11-10
- Mise à jour du dossier source
- 2026-11-10
Ces dates décrivent le dossier source, pas une vérification en direct du recrutement. Consultez l’offre originale.
Détails du poste
| Heures par semaine | 40 (estimé) |
| Déplacements | avion : aucun · route : aucun |
| Milieu de travail | Bureau |
| Position | Surtout assis |
| Exigences physiques | physique faible · ordinateur élevé |
| Langues | English |
| Formation | Baccalauréat (exigé) |
| Domaines d’études | Engineering |
Résumé et détails rédigés par l’IA à partir de l’offre; l’offre de l’employeur fait foi.
GMP Engineering Inc.
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
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