5 дней назад
Process Engineer (OSD)
100 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Process Engineer (OSD): Supporting commercial-stage pharmaceutical manufacturing accounts through process troubleshooting, GMP documentation, and technical client and regulatory communication with an accent on oral solid dose unit operations, equipment, and compliance documentation. Focus on analyzing manufacturing issues, preparing batch and investigation records, and representing operations during client and auditor discussions.
Location: Whitby, Ontario, Canada. Onsite, 5 days per week. Six-month temporary assignment with possible extension.
Expected compensation: 100K; final compensation depends on experience, skills, and qualifications.
Company
is an independent technology consulting firm providing engineering, life sciences, and digital solutions to businesses through an international community.
What you will do
- Act as the onsite technical subject matter expert for a portfolio of 6–7 commercial-stage pharmaceutical client accounts.
- Troubleshoot manufacturing issues escalated from the production floor, with limited floor presence of approximately 30 minutes per day.
- Prepare and maintain GMP documentation, including batch records, technical and investigation reports, feasibility protocols, and scale-up reports.
- Answer process- and equipment-related questions from clients, regulatory stakeholders, and quality auditors.
- Maintain continuity for active client initiatives and coordinate with technical writers and technical project leads on documentation, scale-up, and technology transfer work.
Requirements
- 1–2 years of hands-on oral solid dose process engineering or manufacturing experience, or approximately 5 years of pharmaceutical GMP experience in another area.
- Technical knowledge of oral solid dose operations and equipment, including fluid-bed and high-shear granulation, roller compaction, tablet presses, capsule filling, and film or cosmetic coating.
- Experience with SAP is required.
- Ability to learn proprietary systems and the TrackWise quality management platform; training is provided.
- Strong technical analysis, documentation, client communication, and auditor-facing skills.
- Ability to work onsite in Whitby, Ontario, 5 days per week.
Culture & Benefits
- International community representing more than 110 nationalities.
- Internal Academy with more than 250 training modules.
- Career development environment with many leaders progressing from entry-level roles.
- Regular internal events, including afterworks and team-building activities.
- No Canadian work experience is required.
Hiring process
- Initial brief virtual or phone call.
- Approximately three interviews, depending on seniority requirements.
- Potential case study, technical assessment, role play, or problem-solving exercise.
- Application feedback is provided within a maximum of 45 days from application or the latest interview stage.
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