Utilities Commissioning and Qualification

Utilities Engineer
PharmEng Technology is currently seeking an Utilities Commissioning and Qualification  to join our team for projects in Toronto, ON
Job Description:
•       Must be familiar with design and operation of utilities generation and distribution systems including Clean Steam, Water for Injection (WFI), Reverse Osmosis (RO), and Process Gases (O2, N2, and CO2).
•       Perform routine utilities system audits and collect performance data to optimize equipment operation and increase reliability. Participate in all related internal and external audits as needed.
•       Will work closely with team members from HSE, Quality, and Manufacturing to address operational and compliance issues.
•       Manages all aspects of multiple projects concurrently and work as a team member on select projects. Ability to manage multiple, diverse projects as required. Analyzes, evaluates and designs improvements which meet project objectives to new and existing
•       Processes, equipment and facilities with application of cGMP. Must be able to effectively present design concepts to management for funding approval.
•       Develop and maintain operational SOPs, predictive and preventive maintenance job plans, and equipment logs, many of which may be electronic work instructions.
•       Identify energy savings opportunities and implement recommendations.
•       Assist in developing detailed utilities preventive maintenance programs.
•       Provide training for maintenance staff in efficient utilities operations.
•       Responsible for handling all activities with strict adherence to cGMP, environmental regulations and safety.
•       Continually review and revise existing operating conditions, best practices, and current accepted industry standards.
•       Assist in the scheduling/planning of utilities work for corrective, predictive, preventive and plant shutdown maintenance activities.
•       Responsible for ensuring that all utilities drawings are revised as necessary and up to date.
•       Responsible for all change control requirements for responsible systems.
 
Job Requirements:
·         A minimum of a Bachelor's Degree in Engineering (Mechanical preferred) and 10 years engineering experience in the biotechnology or pharmaceutical industries is required.
·         This individual should be a self-starter with strong interpersonal, organizational and technical skills, with the capability to work both independently and in a team environment at all levels of the organization. Strong analytical and communications skills are critical.
·         Basic understanding of validated and commissioned utilities systems, process gas distribution, water treatment, and process control philosophies.
·         Provide off-hour emergency coverage if required and have the ability to work extended hours to support startup and shutdown activities.
·         Working knowledge of cGMPs, validation principles, sanitization and passivation, operation and certification, and Biopharmaceutical Manufacturing.
·         Working knowledge of facility energy conservation management practices
 
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