Job descriptionWe are seeking a
Process Engineer to support a portfolio of 6-7 commercial-stage pharmaceutical client accounts within an
Oral Solid Dose (OSD) manufacturing environment. This role combines process engineering expertise, GMP documentation, and technical subject matter expertise, with direct collaboration with clients and regulatory stakeholders. The position is primarily desk-based, with most of the time focused on
technical analysis, GMP documentation, and client and regulatory correspondence. Floor presence is limited and primarily required for
escalated troubleshooting.
Location: Whitby, ON
Work Mode: Onsite, 5 days/week
Duration: 6 months, with possible extension
Key Responsibilities - Act as the on-site technical SME for an assigned client portfolio, troubleshooting manufacturing issues escalated from the floor that operations cannot resolve independently (occasional floor presence, approximately 30 minutes per day)
- Generate and maintain GMP technical documentation, including batch records, technical and investigation reports, feasibility protocols, and scale-up reports
- Serve as the direct technical point of contact for clients and regulatory/quality auditors, answering process- and equipment-related questions on behalf of operations
- Maintain continuity on active client initiatives handed off from the outgoing process engineer
- Coordinate as needed with technical writers (documentation support) and technical project leads (scale-up and tech transfer projects)
Qualifications - 1-2 years of hands-on OSD process engineering or manufacturing experience, OR approximately 5 years of general pharmaceutical GMP experience (e.g., liquid dose, sterile) for candidates without direct OSD background
- Technical knowledge of core OSD unit operations and equipment, including: Granulation: fluid bed, high shear, roller compaction; Compression: tablet presses (e.g., Elizabeth Hata, Korsch) and capsule filling; Coating: film/cosmetic coating, O'Hara pans.
- SAP experience required
- Comfort ramping up on proprietary systems and the QMS platform (TrackWise); training provided at start
- Strong client-facing communication skills
- Ability to represent operations confidently to external clients and auditors
- Strong technical analysis and documentation abilities
Expected Compensation Range:100K. The final compensation offered will be
determined based on the candidate's level of experience, skills, and qualifications, in compliance with applicable pay transparency requirements.
Canadian Experience Requirement:No Canadian work experience is required for this position. Candidates are encouraged to apply regardless of previous Canadian experience.
Artificial Intelligence (AI) Disclosure:No Artificial Intelligence (AI) tools are used in the screening, assessment, or selection of candidates for this position. All stages of the recruitment process are conducted by human recruiters and hiring managers.
Statement Regarding Job Vacancy:This position is a
Job creation, created to support ongoing project needs.
Recruitment Process & Feedback Timeline:Candidates will receive
feedback on their application within a maximum of 45 days from the date of application or from their most recent interview stage.
