Validation Engineering Specialist

1 week ago

Mississauga, Ontario, Canada Thermo Fisher Scientific Full time
12-Month Co-Op Opportunity for Eligible Students in a Co-Op Program

Summary: This position offers specialized validation expertise essential to support operations and clients effectively. Responsibilities include conducting equipment, process, and new product validation protocols, as well as reviewing final reports for approval ensuring compliance with standard operating procedures, client specifications, and Good Manufacturing Practices.

Essential Functions:
  • Prepare Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) for complex equipment, facilities, and computer systems.
  • Develop and execute process validation protocols for both new and existing clients, including report writing.
  • Manage documentation and retention rooms.
  • Review and validate data.
  • Monitor cleaning processes and analyze results trends.
  • Offer technical support to Quality Operations, Project Management, and more.
  • Assist in special projects when needed.
  • Prioritize a safe work environment and report any potential risks.
  • Be open to alternating or rotating shift work.
REQUIRED QUALIFICATIONS:

Education: High school diploma or General Educational Development (GED) Certificate with a focus on chemistry or related field.

Experience: Previous experience in validation or a science-related setting.

Skills and Abilities: Strong written and verbal communication skills, attention to detail, organizational proficiency, excellent interpersonal skills, problem-solving capabilities, multi-tasking abilities, data analysis knowledge, and proficiency in Microsoft Office tools and the English language.

Standards and Expectations:

Adhere to Environmental Health & Safety Policies and Procedures. Collaborate effectively with team members to achieve project goals while complying with quality systems and GMP. Maintain a clean workspace and engage actively in departmental systems for efficient workflow. Stay alert to client needs and display patience. Aim to enhance team performance by identifying improvement opportunities. Adapt to changes positively and communicate effectively.

Stay focused on upholding Key Performance Indicators and seek continuous improvement. Proactively communicate risks and seek personal development.

Physical Requirements:

This role necessitates basic physical coordination for lab activities, including standing, walking, lifting light to medium weights periodically, dexterity for typing and equipment operation, visual acuity, and auditory skills. Protective gear required occasionally.

Disclaimer: This job description outlines the general requirements for this position. Assignments of additional duties may occur as necessary without creating an employment contract. The description aligns with legal obligations and equality directives.

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