Validation Engineer I

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Consistency to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

A day in the Life:

As a Validation Engineer, you will collaborate with multiple departments to support the validation and qualification of computer systems, equipment, processes, utilities, and facilities at the site. Your role will involve ensuring site compliance and timely execution of crucial activities to maintain the validation of all GxP systems.

Job Description

Key areas of accountability/responsibility

• Represent Thermo Fisher as (support) technical project lead, in customer communications and internal discussions.
• Provide support in technical and technological expertise to steer decisions in preparation for, during and after manufacturing activities.
• Support process validation studies by coordinating (and completing) studies, ensure running activities are on track and accurate completion of approved validation reports.
• Lead progression of assigned projects, communicate risks timely and seek to resolve challenges, both internally and externally.

• Responsible for performing Validation activities, with responsibility for results on Safety, Quality, and Quantity:

• Responsible for achieving the Validation Master Plan in line with business needs and strategy\

• Responsible for continuous improvement in costs and results within validation activities

• Ensure individual trainings are up-to-date and aligned to Thermo Fisher guidelines and systems.

• May act as domain guide in GMP-compliant trainings.

• Works with functional managers to ensure knowledge and skills are captured in a balanced manner.
• Follows EH&S guidelines and when vital, chip in to EH&S improvement activities.
• Perform other duties as assigned.

Knowledge and education level

• Higher vocational education, BSc or equivalent level through education, training, and experience in Validation,  Engineering, and/or Chemical Technology;
• Good command of English, both in oral and written communication;
• Excellent Knowledge and experience in EH&S;
• Excellent Knowledge and experience in facilities for manufacturing of biologics.

Required level of experience

• Proven experience in a Validation role and/or Technical role;
• Experienced in a Biotech/ Biopharma/ cGMP environment.

Competence

• Clear communicator.
• Data-driven problem solver.
• Excellent planning and organization skills.
• High degree of self-awareness