Manager Validation

Work Schedule

Environmental Conditions

Job Description

How will you make an impact:

Manages the validation staff to meet customer and client requirements and provides standards and direction to the site and clients in meeting Good Manufacturing Practices (GMP) requirements in the area of Validation. Interacts with various departments within Operations and Pharmaceutical Development Services (PDS) to resolve validation issues, ensures proper documentation, and completes all validation documentation to meet the Manufacturing Production Schedule (MPS). Additional duties include Deviation Report (DR) inputs, client or vendor validation protocols and reports approval.

What will do you:

• 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 validation activities such as Data Integrity (DI) and Continuous Process Verification (CPV).
• Participate in strategy meetings with other departments to develop Validation guidelines.
• Plan and implement all validation projects for the department.
• Review validation protocols and create/update Standard Operating Procedures (SOPs) for the department.
• Act as the liaison between Thermo Fisher and the client company regarding validation issues.
• Schedule and manage day-to-day activities in the department as wells prepare and circulate departmental activity reports and schedules.
• Coordinate validation activities with other departments to insure project completion and timeliness.
• Provide input in the preparation of project proposals and budgets for validation activities.
• Provide input in investigations and attends meetings discussing commercial processes with ongoing problems.
• Promote a safe working environment, report potential hazards and ensure all direct reports follow the Environmental Health and Safety procedures.
• Select, develop and evaluate staff to ensure the efficient operation of the function. Work with and advise staff on administrative policies and procedures. Recommend changes in staffing and budgets as needed. Staff may include internal and third parties.

How will you get here:

Education:

Bachelor's degree in science, engineering, pharmacy or business.

Experience:

Minimum 7 years' previous experience in Validation, Quality Assurance, Regulatory or relevant contract manufacturing cGMP regulated environment.

Minimum 3 years' previous supervisory experience.

Previous project management and/or client experience.

Equivalency:

Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills, Abilities:

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 as well as directly with clients. 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. Carry out all duties within 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 adhere to 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 in related field.

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 regular 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.

Benefits

We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, company savings plan, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.