Validation Specialist – cGMP, Global Impact & Growth

1100 Mylan Pharmaceuticals Inc.; Mulhuddart; On-site; EUR 55,000 - 75,000; Full time

Job summary

Viatris is seeking a Validation Specialist to drive process validation/qualification across multiple production areas, including writing, executing and reporting validation activities in a cGMP environment.

Ideal candidates will have a Bachelor's degree in a relevant field, hands-on validation experience, and strong technical writing and communication skills to collaborate with project teams and manage multiple priorities.

Qualifications

• Bachelor's degree in Science, Engineering, Technology or a related discipline.
• Hands-on experience working as a validation engineer/specialist in a cGMP environment, preferably in an oral solid dose facility.
• Full understanding of cGMP requirements, including Annex 11 and Annex 15.
• Effective technical writing skills.
• Excellent interpersonal, leadership, communication (written and verbal) and time-management skills.
• Flexible and able to manage multiple priorities simultaneously.

Responsibilities

• Process Validation/Qualification projects across a range of production areas (Process, Cleaning, Software, Utility and Facility).
• Generation, execution and close out of validation projects for existing products and new product introductions.
• Writing, executing & reporting of validation activities (FAT / IQ / OQ / PQ / FMEA Risk Assessments / PVP).
• Participate in project teams and assist in determining schedules and levels of validation.
• Execute and document risk assessments (FMEA) related to validation activities.
• Perform validation functional testing as required.
• Track and resolve deviations during qualification activities.

Skills

Validation engineering

cGMP experience

Technical writing

Communication

Education

Bachelor's degree in Science, Engineering, Technology or related discipline

Job description

Viatris is seeking a Validation Specialist to drive process validation/qualification across multiple production areas, including writing, executing and reporting validation activities in a cGMP environment.

Ideal candidates will have a Bachelor's degree in a relevant field, hands-on validation experience, and strong technical writing and communication skills to collaborate with project teams and manage multiple priorities.