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Validation Engineering Specialist III

3 months ago

Whitby, Canada Thermo Fisher Scientific Full time

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

Summary:

Provide specialized cleaning validation knowledge and information, which is directly needed to support operations and clients. Complete protocols and reports related to the cleaning validation of manufacturing and packaging processes. (including serialization), Continues Process Verification (CPV), equipment qualification and cleaning. Ensure documents conform to all ThermoFisher Standard Operating Procedures (SOPs), client requirements, and Good Manufacturing Practices.

REQUIRED QUALIFICATIONS

Essential Functions:

  • Provide leadership to Validation Engineering Specialist I&II by supporting problem solving and solution generation on projects, training/mentoring, and supporting project progression.
  • Prepare and execute process validation protocols (new and existing clients) and writing write reports.
  • Review documents from team members and act as validation manager designate.
  • Provide guidance to junior members on various validation requirements and strategy strategies (through team meetings and individual interactions).
  • Review and approve assessments, deviations; change controls and protocols/reports as well as Master Validation Plan.
  • Review/verify data and performsperform statistical analysis.
  • Monitor the production scheduling and coordinates coordinate validation activities as required
  • Lead cleaning validation program.
  • Support equipment swabbing (as required)
  • Perform and approve 5 years qualification reviews.
  • Attend client meetings as validation lead (as required)
  • Update assigned Master Validation Plans (MVPs) as per validation policy.
  • Provide audit and regulatory support.
  • Lead/facilitate technical investigations and Corrective Action Preventative Action (CAPA) implementation.
  • Support special projects (as required)
  • Perform alternating or rotating shifts (ifas required)

Education:

BSc in Chemistry, Engineering, or related field.

Experience:

Minimum 5 years experience in validation within the pharmaceutical industry with focus on cleaning validation.

Previous experience in project management and statistical analysis is preferable.

Equivalency:

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

Knowledge, Skills and Abilities:

Strong written and oral skills. Detail oriented and organized, with a high degree of accuracy and thoroughness. Excellent interpersonal skills, communication and organizational skills. Strong judgment, decision making and trouble shooting skills. Ability to multi-task, meeting tight deadlines in a fast paced environment. Mini-T and data analysis knowledge an asset. 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. Effectively 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. Model 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:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about lab/lab office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.

Disclaimer:

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as a comprehensive statement of work, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully align with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.