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Process Engineer/ Investigator

3 months ago

Windsor Ontario KU, CA ASM International Full time

Join a Market Leader

Hovione is an independent family owned international group of companies. From the beginning, we have set ourselves above and apart through our innovative technological and productive capabilities, reaching a top spot in the world market as an integrated Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and off-patent drugs to market.

Our people are the main asset for our continued success. Reaching over 1950 team members, from 36 different nationalities, that are located across Asia, Europe and North America (Portugal, US, Macao, Ireland, China, Hong Kong, Japan, India, and Switzerland), including 4 production sites.

Working at Hovione means reaching for innovation and excellence in everything we do: for our clients, our partners and, above all, our patients. That is why we are In it for life.

You will be responsible to:

  1. Enable the efficient manufacture of pharmaceutical products, including highly potent compounds, in compliance with applicable cGMP and HSE regulations and in accordance with business requirements.
  2. Manage activities directly related to the life cycle of Manufacturing deviations and events to ensure that they are completed consistently and in a timely manner.
  3. Ensure the use of the best process engineering knowledge is applied in tech transfers and scaling up oral dosage form projects to maximize customer satisfaction and Hovione’s interests and in compliance with all Federal, State, Local and internal policies.

Specific responsibilities include:

  • Participation in the Area actions defined in continuous improvement plans related to HSE, Quality and Productivity.
  • Ensure that all Operations events and deviations are issued, investigated (if applicable) and completed within required timeframes and in accordance with regulatory and internal requirements.
  • Monitor the status of open events and deviations and provide regular status reports to DPCM Leadership.
  • Perform trending of the direct causes/root causes of events and deviations and issue periodic reports summarizing the information to QC Leadership.
  • Plan and design methods to improve efficiency in production.
  • Participate in all necessary EHS training (i.e. hazardous waste management) and monthly meetings.
  • Maintain open communication with other employees and management concerning EHS topics, including documentation of incidents and/or issues.
  • Prepare scientifically sound reports (campaign, monthly, deviation investigation, others) in a timely manner.
  • Train operations personnel on the use of production systems and procedures.
  • Initiate events and deviations in the CAPA system within the required timeframe.
  • Complete the description portion of the event or deviation, along with a member of Quality Assurance, within the required time frame.
  • Assess all data and information associated with the investigation of the event or deviation to determine the appropriate next steps, in accordance with the approved workflow.
  • Guide the Process Engineers (or other TM’s as applicable) in the necessary investigative testing to be performed to identify the root cause of the event or deviation, in accordance with the approved workflow.
  • Document all information related to the investigation of events and deviations and gather all pertinent support evidence and/or documents.
  • Determine the root cause of events and deviations based upon the data and information obtained through the investigation.
  • Determine appropriate corrective and/or preventative actions (CAPA), where applicable, based upon the findings of the investigation.
  • Monitor the status of open events and deviations and provide regular status reports to DPCM Leadership.
  • Perform trending of the root direct causes/root causes of events and deviations, and issue reports to DPCM Leadership.

We are looking to recruit a Candidate:

  • A minimum of BSc in Chemical Engineering and a minimum of 1 to 3 years of industrial experience in either a chemical or pharmaceutical environment, as a process engineer in a manufacturing facility performing the various aspects of a Process Engineering role.
  • Able to understand the impact of decisions and actions in other areas.
  • Able to communicate and motivate the team to accomplish success in the execution of projects.
  • Able to make coherent decisions in the processes based on defined priorities and the best judgment of the technical data available.
  • Lean and 6 Sigma training equivalent to Lean Leader level and/or Six Sigma Green Belt (preferred).
  • Maintain knowledge and understand cGMPs as per ICH Q7 and CFR21 parts 210 to 211.
  • Result driven, team player and able to deal with multiple projects/tasks.
  • Leadership, Team Management and Communication skills.
  • Business sense.
  • Creative, problem solver, organized.
  • Experience with Lean tools and techniques (5s, Standardized Work, problem solving, kaizen, process mapping, Poka Yoke, debottlenecking, SMED).

Hovione is a proud Equal Opportunity Employer

Inclusion and diversity are key to us. At Hovione, that means a work environment where differences are valued, and everyone is treated with fairness and respect. We want all our team members worldwide to feel supported, respected, and have the opportunity to achieve their full potential, regardless of their age, gender, religion, disability, sexual orientation or ethnicity.

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