Senior Validation Engineer

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degrees, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Position Summary:

Join Thermo Fisher Scientific Inc. as a Senior Validation Engineer and be part of a remarkable team that strives for flawless execution and world-class standards. In this role, you will assist the Equipment, Utilities, and Facilities Validation department in maintaining a lifecycle approach in line with regulatory guidelines, the Site Validation Master Plan, project-specific Validation Plans, and departmental SOPs. This is an outstanding opportunity to impact the manufacturing of biopharmaceutical products by ensuring compliance with international quality requirements.

Key Responsibilities:

• Assist Validation Department for commissioning and qualification of Equipment, Facilities and Utilities, in compliance with pertinent regulations (e.g., TGA, FDA, EMA). Coordinates tracking of validation protocol execution status and ensures completion of validation projects per required schedules.
• Preparing, execution and/or review of validation documentation, including and not limited to FDS, DQ, IOQ PQ, CSV etc. Track and resolve anomalies during qualification activities.
• Development of project plans for validation processes.
• Provide validation support and associated mentorship for equipment, facility and utilities qualification processes.
• Represent validation at external and internal audits.
• Responsible for performing validation activities and achieving:
  • assigned targets, standards and/or departmental goals
  • priorities in the planning of actions and resources
  • strategic goals set for the department, which are in line with the company goals
  • yearly plans of the department
• Responsible for achieving cost consciousness within the department
• Be a role model for the Validation systems and policies for Brisbane site
• Supervise external technological, legal and regulatory developments around Validation and assess their applicability to and consequences for Brisbane site. Harmonise with validation teams in other BIO sites to identify and implement standard methodologies.
• Responsible for continuous improvement in costs and results within validation activities.
• Responsible for EH&S in Validation activities
• Assist validation contractors to meet current and future requirements in terms of quality and quantity to establish and maintain cGMP compliance
• Leads and supervises the execution of all relevant validation activities within the Manufacturing and Laboratory areas, integrating their timeline with ongoing projects and programs.
• Responsible for EH&S in assigned Validation activities, including:
  • Maintaining a safe and balanced working environment
  • Champion the awareness for EH&S and Quality within department.

Education:

• Bachelor’s degree in Science, Engineering, or Statistics, or meaningful work experience.

Experience:

• Preferably 5 years of confirmed Biotech experience in commercial-scale manufacturing operations.

Knowledge, Skills, Abilities:

• Strong communication and interpersonal skills.
• Good presentation, planning, and organizational skills.
• Confirmed leadership and mentorship abilities.
• IT foresight and adaptability.
• Ability to collaborate with complementary teams.
• Demonstrated dedication to continuous improvement and customer focus.
• Ability to balance multiple projects and tasks simultaneously while meeting agreed due dates.
• Strong attention to detail and dedication to quality orientation principles.