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.
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.
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 www.evonik.com/en/careers.html.
Please address your application to the Talent Acquisition Manager, stating your earliest possible starting date and your salary expectations.
Your Talent Acquisition Manager:
Robin Rose
Company is
Evonik Canada Inc.
