- 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 current 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.

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 c

📌 Plant Engineer (Canada)
🏢 BioTalent Canada
📍 Canada