Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
Job Description
How will you make an impact?
Lead the packaging mechanics, specialists, and set up technicians to meet site and customer requirements for new and modified packaging equipment. Provide standards and direction to the site and customers in meeting Good Manufacturing Practices (GMP) requirements and implement best practices around Equipment Commissioning and Qualification. Interact cross functionally to implement equipment solutions and resolve major equipment issues, including Deviation Report (DR) input as the need arises. Lead the sourcing and application of packaging technology to deliver the future state of packing automation in Operations. Ensure all packaging equipment PMs are scheduled and completed on time.
What will you do:
- Mentor, guide and coach the department team from a technical perspective to increase level of knowledge and expertise.
- Seek and bring ideas with regards to automation, industry benchmark and Regulatory guidelines to support site growth, efficiency, and compliance.
- Support Corporate equipment improvement activities such as Data Integrity (DI) and Pharma 4.0.
- Participate in strategy meetings with other departments to develop Equipment Qualification guidelines.
- Plan, prioritize and implement full life cycle equipment projects.
- Review equipment qualification protocols and create/update Standard Operating Procedures (SOPs) as the need arises.
- Schedule and manage day-to-day activities in the department as well as prepare and circulate departmental activity reports and schedules, including team metrics.
- Provide guidance in the preparation of project proposals and budgets for equipment CAPEX activities.
- Provide input in investigations and attend meetings discussing commercial processes with ongoing problems.
- Support and resource Capital Engineering Projects, PPI, and New Business needs with respect to Equipment implementation (URS through Qualification).
- Select, develop, and evaluate colleagues to ensure the efficient operation of the function. Advise colleagues on administrative policies and procedures. Recommend changes in staffing and budgets as needed. Colleagues may include internal and third parties.
- Promote a safe working environment, report potential hazards, and ensure all direct reports follow Environmental Health and Safety procedures.
How will you get here:Education: College/Technical School diploma in related technical field.
Bachelor's degree in engineering preferred
Experience: Minimum 5 years previous combined experience in Equipment Project Management and Qualification in a cGMP regulated environment.
Minimum 2 years previous supervisory experience in related field.
Equivalency: Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills, and Abilities:Strong mechanical knowledge of Manufacturing equipment including control systems. Strong knowledge and understanding of manufacturing/operational processes. Excellent knowledge of Good Manufacturing Practices and Food and Drug Administration (FDA) compliance knowledge. Strong interpersonal and communication skills (both oral and written). Ability to motivate and influence. Ability to meet deadlines and prioritize multiple project deliverables. Comfortable dealing with all levels in the organization. Excellent verbal and written communications skills with the ability to build and drive cross-functional teams. Strong customer focus and commitment to results with strong problem-solving abilities. Adept at setting clear priorities, organizing work, and making quality decisions in a fast-paced business setting. Demonstrated computer proficiency with Microsoft Office programs. Proficiency with the English Language.
Standards and Expectations: Follow all Environmental Health & Safety Policies and Procedures. Work collaboratively with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives. Perform all duties with strict compliance to Patheon quality systems Standard Operating Procedures (SOPs) and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Actively engage in and enforce departmental systems to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.). Be client and patient conscious at all times. Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving. Models positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working. Proactively identify areas for improvement in the execution of procedures. Communicate risks to timelines in a proactive manner. Consistently strives to improve skills and knowledge.
Physical Requirements: Light physical effort and fatigue. Walks, sits, or stands for limited periods. May require occasional equipment operation including keyboard equipment. Lifts light items for limited duration. Typically located in a comfortable indoor area. There may be exposure to mild physical discomfort from factors such as dust, fumes or odours, temperature extremes, loud noise, strong drafts, or bright lights. Use of Personal Protective equipment may be required and may include any of the following: safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator on occasionally.