Quality Project Specialist/Lead (GMP)
- 6-month contract position to start, with potential to become permanent
- GTA-based position – work remotely, with occasional travel to client sites across the GTA
- Perfect opportunity for an intermediate-level engineer with quality and validation experience in the pharmaceutical industry
- Target salary range starting at $80,000/year+, negotiable on experience
- P. Eng is an asset but is not required
Who are you?
You’re a motivated, intermediate-level Engineer, with strong experience with GMP in the pharmaceutical industry, and a strong desire to lead and execute projects alongside a dedicated team.
You’re interested in working with a diverse, progressive, and close-knit team, in a company that values coaching and mentorship for staff at all levels.
If you are resourceful, organized, have great client communication skills, and are excited by the opportunity to make a meaningful contribution to a number of exciting projects, this could be your next role.
Who is the employer?
Our client is a Canadian engineering and compliance firm, specializing in equipment engineering, project management, and compliance and validation. Established over 20 years ago, they serve medium to large clients in regulated industries (pharmaceutical, medical device, nutraceutical, cosmetics, and more).
They offer a close-knit, flexible company culture and small team environment, with a management team that prioritizes mentorship, learning, and professional development. And, right now, they’re busier than ever – which is why they are looking for you.
What you’ll be doing
As the new Quality Project Specialist/Lead, you will focus on leading and executing equipment and facility validation projects with clients in the pharmaceutical industry.
You’ll split your time between drafting and writing validation protocols, executing the protocols, and supporting other more junior consultants with validation and quality questions. With your strong understanding of pharmaceutical GMPs, you will serve as a valued resource and guide to team members as you collaborate with them to lead and execute on projects.
Your responsibilities will include:
- Establish project work plan (duties, responsibilities) based on work level/competency of team members
- Coordinate the planning, organization, control, and execution of quality projects against project deliverables
- Lead and execute 4-5 small-medium sized projects.
- Provide quality reviews as required for engineering project documentation, including URSs, SOPs, and Validation (IQ/OQ/PQ) protocols
- Collaborate with other team members to provide quality advice and issue resolution
- Provide regular status updates to customer and internal team on quality related projects
- Prepare project reports as requested for client and management
- Maintain knowledge of current industry practices and recent developments in regulations pertaining to GMP Quality
Here’s what we need:
- Minimum BSc Degree in Science or Engineering related area.
- 4+ years of GMP experience in the pharmaceutical industry, with previous experience as a quality engineer, quality lead, validation lead, or project lead preferred
- Quality experience in equipment, process and computer validation is essential, with focus on data integrity.
- Demonstrated ability to effectively lead and execute multiple projects/priorities.
- Strong work ethic, excellent interpersonal skills, organizations, verbal, and written communication skills.
- Proficient MS Office applications such as Word, Excel, PowerPoint, Project.
- Ability to travel and work at client sites across the extended GTA as required.
And here’s what would be a bonus:
- P. Eng in Ontario would be considered an asset, but is not required
- Consulting experience would be an asset
We value diversity and inclusion and encourage all qualified people to apply. We encourage all qualified candidates to apply; however, only those selected for an interview will be contacted.
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