Plant Engineer

• Plan, Coordinate, and Execute assigned projects by effectively using Project Management methodologies
• Execute assigned projects from Conceptual design to Financial close.
• Execute project activities in alignment with Good Engineering Practices (GEP) including but not limited to SOW development, vendors/contractor identification, change control management, author / execute / summarize ETOPs and validation protocols, and author SOPs or provide technical review.
•  Read and review engineering drawings and update as required.
•  Follow SOP’s, cGMP, and GLP regulations and procedures; generate and maintain thorough and accurate documentation by using Good Documentation Practices (GDP) in support of SOP, cGMP, and GLP regulated activities.
• Develop and execute Commissioning & Qualification protocols.
• Identify Continuous Improvement (CI) opportunities related to Facility maintenance, calibration, and facilities equipment, and procedures. Take corrective action independently and/or as directed by management.
•  Assist in development and review of Technical manuals as required.
•  Assist in development and review of Preventive Maintenance checklist and/or Guidelines and Calibration specifications as appropriate.
• Prepare supporting documentation for projects of diverse scope and complexity. 
•  Equipment design and selection; line design and installation
• Incorporate Pharmaceutical Standards and cGMP’s into assigned projects as appropriate, i.e. USP and/or EU Standards.
•  Provide training and/or technical support as needed.
•  Serve as primary author for technical reports and summaries for small projects of varying scope and complexity

REQUIREMENTS

• BS in a relevant engineering field (preferably in Chemical or Mechanical Engineering).
• Three to Five (3-5) years commissioning and qualification experience in a highly regulated industry, preferably the pharmaceutical or medical device industry.
• Knowledge of FDA, ISO, EU and Health Canada regulatory requirements and cGMP.
• Knowledge and experience in the interpretation of GAMP, GEP, and ISPE guidances.
• 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.