Plant Engineer

Evonik; Burnaby; On-site; CAD 70,000 - 94,000; Full time

Job summary

Evonik Vancouver Laboratories is seeking a maintenance project engineer to drive cGMP‑compliant projects. You will manage calibration activities, maintenance schedules and CQV efforts, while collaborating across functions to resolve equipment issues.

The role requires a BS in Engineering and 3+ years in regulated environments, with knowledge of FDA/ISO/ICH/EMA and Health Canada standards. Strong technical communication and problem‑solving are essential.

Qualifications

• BS in a relevant Engineering field.
• 3+ years engineering/maintenance project execution in a highly regulated industry.
• Knowledge of FDA, ISO, ICH, EMA and Health Canada regulatory requirements and cGMP.
• Knowledge of IT/OT and Computer System Validation is an asset.
• Knowledge of GEP and ISPE standards.
• Experience with risk assessments and root cause analysis.
• Ability to apply Quality by Design / Lean Six Sigma concepts.

Responsibilities

• Execute assigned projects using Project Management methodologies per GEP.
• Oversee and perform calibration activities for manufacturing equipment.
• Implement maintenance schedules to maximize reliability and minimize downtime.
• Support CQV activities for new and existing equipment and document regulatory compliance.
• Collaborate with cross‑functional teams to troubleshoot asset issues and implement solutions.
• Participate in root cause analysis and corrective actions for failures or non‑conformances.
• Conduct inspections and audits to ensure safety and quality standards.
• Identify continuous improvement opportunities related to maintenance.
• Review engineering drawings and provide input to design teams.
• Follow cGMP, GLP, and GDP; maintain thorough documentation.

Skills

Project management

Calibration

Maintenance planning

CQV

Cross-functional collaboration

Root cause analysis

Regulatory knowledge

Communication

Education

BS in Engineering

Job description

Target Salary Range: $70,200 – $93,600 per year (salary to be determined by education, experience, knowledge, skills and abilities of applicant, internal equity, and alignment with market data)

EVONIK Vancouver Laboratories (VAN), the operating drug delivery service site of Evonik Canada Inc., is a Contract Development and Manufacturing Organization (CDMO) that provides CMC services to biotechnology and pharmaceutical companies engaged in the development and manufacture of complex delivery-based drug formulations. EVONIK has a successful track record of helping Customers move their programs forward. Evonik’s Vancouver business operations is a development partner to the world’s pharmaceutical companies for parenteral lipid nanoparticle drug products. As an enabling contract development manufacturing organization (CDMO) partner, we offer drug formulation design, process development, scale‑up, and clinical production. EVONIK’s range of services extends from initial formulation prototype identification, manufacturing process development & scale‑up, analytical method development & validation to support raw material, in‑process, release and stability testing, all the way through to sterile product manufacturing under GMP for Phase I-II clinical trials. Products include the LIPEX® line of Extruders, which are designed to enable small‑scale to commercial scale manufacturing of liposomal drug products.

With over 25 years of experience and having transacted business in about 50 different countries, WHY EVONIK? Evonik offers an excellent Total Rewards Program including: Competitive base compensation & bonus; employer paid health & dental benefits complimented with wellness education sessions; Financial planning resources & savings plans including RRSP & Defined Contribution pension plans; Generous vacation and paid time off to support Community Volunteer activities; Financial assistant for fitness memberships. And there is more…access to a Comprehensive Health Promotion program and Regional and Global resources for ongoing training and development. Best of all, you will work within a great team of professionals in an engaging workforce who value trust and openness.

Are you looking to join a dynamic company with an exciting and expanding future in the pharmaceutical industry? Then Evonik is the next step in your career.

Grow with us!

Vancouver has something for everyone! British Columbia is beautiful and exciting. From the people, to the mountains, to the sprawling coastline, everywhere you look. Nestled on the warm Pacific Coast with the Rockies blocking cold arctic winds. Vancouver has the good fortune of being spared the typically chilly winters associated with Canada. Vancouver is often called ‘two cities in one’ because people are equally prone to enjoy the bustling nightlife and experiencing a plethora of activities in the surrounding nature. Imagine enjoying a day‑long trek through our world‑renowned rain forests, then heading into the city for a night out. Vancouver truly is as beautiful as people say and more.

What we offer At Evonik, you’re part of a global chemical company working in many sectors that go beyond chemistry. From lipids for tomorrow’s medicines, biosurfactants for green detergents, additives for plastics recycling or membranes to help drive forward the energy transition, you’ll play an essential part in helping the world’s most essential industries succeed. Our success hinges on a diversity of ideas powered by people, not egos. Whether you’re a scientist or engineer, new to the team or established, in business, production, or anything in between – we cheer each other on. Because we believe we can do anything. Explore everything. And Be Part of Something Special! Find out more about the many benefits we offer: https://www.evonik.com/en/careers/why.html

Meet the team and get to know the people behind Evonik: https://www.evonik.com/en/news/meet-the-team.html

RESPONSIBILITIES

• Execute assigned projects by effectively using Project Management methodologies in alignment with Good Engineering Practices (GEP).
• Oversee and execute calibration activities for manufacturing equipment to ensure compliance with industry standards.
• Implement maintenance schedules to maximize equipment reliability and minimize downtime.
• Support commissioning, qualification, and validation (CQV) activities for new and existing equipment and processes and maintain appropriate documentation in accordance with regulatory requirements.
• Collaborate with cross‑functional teams to troubleshoot equipment/asset issues and implement effective solutions.
• Participate in root cause analysis and corrective action initiatives to address equipment failures or non‑conformances.
• Conduct regular inspections and audits of equipment and systems to ensure adherence to safety and quality standards.
• Identify Continuous Improvement opportunities related to maintenance.
• Read and review engineering drawings and provide technical input to design firms if necessary.
• Follow SOP’s, cGMP, and GLP regulations and procedures; generate and maintain thorough and accurate documentation by using GDP in support of regulated activities.
• Contribute to equipment design discussions and selection as directed by management.
• Contribute to the development of site’s equipment strategy to ensure an optimal equipment life cycle is managed appropriately
• Contribute to the site’s strategic capital projects
• Responsible to meet fundamental cGMP requirements relating to conduct and work practices to ensure Safety, Identity, Strength, Purity, and Quality (SISPQ) of products manufactured at Vancouver Laboratories. This includes but is not limited to the following:
• Initiate and/or support the creation and resolution of engineering related Deviations, CAPAs, and Change Controls.
• Support with internal and client‑driven audits during area inspections and follow‑up observations
• Review and approve maintenance reports.
• Review and approve validation protocols.
• Adhere to EHSS programs, rules, and procedures

REQUIREMENTS

• BS in a relevant Engineering field.
• 3+ years engineering/maintenance project execution and plant experience in a highly regulated industry, preferably the pharmaceutical or medical device industry.
• Knowledge of FDA, ISO, ICH, EMA and Health Canada regulatory requirements and cGMP.
• Knowledge of IT/OT and Computer System Validation is an asset
• Knowledge and experience in the interpretation of GEP and ISPE standards.
• Experience with risk assessments and mitigations, root cause analysis and risk/hazard/failure analysis.
• Able to apply principles of Quality by Design, Design for Six Sigma, Lean Six Sigma, etc.
• Experienced in the use of word processing, spreadsheet, and presentation software programs.
• Effective written and verbal communication skills; ability to clearly and effectively communicate observations, results, and outcomes to more senior technical staff.
• Conduct activities with consideration of budget, time schedules, and overall project goals and objectives.
• Actively contribute to the improvement of policy, practices, and procedures.

This is your opportunity to join a thriving global organization that combines cutting‑edge science, technology and engineering with world‑class business services to create solutions that answer real‑world problems. If you join us, we’ll expect you to take ownership of your work, team up with other great minds, and add your name to creations that make a positive difference for generations. As one of the world leaders in specialty chemicals operating in more than 100 countries with over 32,000 employees, we need your diversity of thought to make us better. In return for your passion, initiative and creativity, you’ll enjoy opportunities to improve and to be respected for your contribution.