Salary Range: Min $75,600 - Midpoint $100,800 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! Click here to learn more from our Vancouver Laboratories employees: https://www.youtube.com/watch?v=s5X15sKUEzs WHY VANCOUVER? 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 Explore a world of opportunities with us. Look ahead with us and help shape innovative solutions to make our world more sustainable and life healthier, more vibrant and more comfortable. At Evonik, you have the chance to explore, thrive, and grow alongside 33,000 colleagues. Among attractive career paths and high-quality development programs, we not only offer performance-based remuneration and occupational health benefits but also hybrid and flexible working environments with #SmartWork. Bring your fresh perspective, develop your strengths, break out your mold, and find a career that fits your dreams with us. Click on the link below to learn what our employees have to say about Evonik: https://careers.evonik.com/en/about/meet-the-team/ Plan, coordinate, execute, and close assigned projects by effectively using Project Management methodologies and communicate with other departments and vendors regarding progress, impact, and completion. Act as the Lead for cross-functional projects to drive the goals of the Site Engineering department. Manage on-site contractors for routine/corrective maintenance and calibration activities. Support the installation, commissioning, qualification, and validation of new equipment and systems. While collaborating with engineering, operations, and quality assurance teams to establish site maintenance and validation strategies. Coordinate and execute QMS processes and procedures related to engineering projects, such as Risk Assessments, Change Controls, Deviations and Root Cause Analyses in the event of identified observations Serve as primary author for SOPs, validation protocols, technical reports, and execute tasks in alignment with Good Engineering Practices (GEP). Follow SOPs, cGMP, and GLP regulations and procedure; generate and maintain thorough and accurate documentation by using GDPs in observation of these regulations. Identify and execute Continuous Improvement (CI) opportunities related to facility maintenance, calibration, equipment, and procedures. Take corrective action independently and/or as directed by management. Conduct safety inspections and report findings to EHSS. Respond to facility emergencies, and ensure safety of works and property. Requirements: MS/BS in a relevant engineering field (preferably in Chemical or Mechanical Engineering) with 3+ years experience in a highly regulated industry, preferably the pharmaceutical or medical device industry Knowledge and experience in the interpretation of GAMP, GEP, and ISPE guidance, and regulatory requirements for cGMP operations and electronic systems (FDA, ISO, EMA, and Health Canada). Knowledge of aseptic processing is an asset. Experience with process and equipment qualification such as commissioning and IOQs. Knowledge of utility systems (HVAC, purified water, air compressors, boilers, etc.) CAD skills (AutoCAD preferred) an asset. 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. Excellent communication skills in English, written and verbal with a collaborative, solution-focused approach. Keen attention to detail with a focus on safety Your Application To ensure that your application is proceeded as quickly as possible and to protect the environment, please apply online via our careers portal. Further information about Evonik as Employer can be found at https://careers.evonik.com. Please address your application to the Talent Acquisition Manager, stating your earliest possible starting date and your salary expectations. Your Talent Acquisition Manager: Minnie Khera Company is Evonik Canada Inc. 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. Click here to learn more about Evonik from our employees
