Manager Packaging Mechanics & Projects

at  Thermo Fisher Scientific

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.

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.

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.

• 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.