Process Validation Specialist (cGMP Biotech)

BioMarin Pharmaceutical Inc.; Ireland; On-site; EUR 60,000 - 80,000; Full time

Job summary

A global biotechnology company is seeking a Process Validation Specialist in Ireland. This role involves overseeing process validation in a cGMP environment, coordinating multiple validation projects, and assisting with regulatory filings. Ideal candidates will have a technical degree, 8+ years of experience in a regulated environment, and strong communication skills. The company fosters an inclusive workplace and is committed to employee growth and innovation, ensuring compliance with the highest standards in drug manufacturing.

Benefits

Career development opportunities

Inclusive work environment

Flexible work conditions

Qualifications

• 8+ years in a cGMP regulated manufacturing environment, with expertise in process validation.
• Ability to communicate and present data to various audiences.
• Strong organizational skills for managing multi-discipline project groups.

Responsibilities

• Perform process validation activities for drug substance and products.
• Assist with regulatory filings and inspections.
• Develop and implement SOPs and guidelines.

Skills

Process validation

Project management

Technical writing

Regulatory compliance knowledge

Communication skills

Education

Bachelor's degree in a technical discipline

Tools

MS Word

MS Excel

MS Project

MS PowerPoint

Job description

A global biotechnology company is seeking a Process Validation Specialist in Ireland. This role involves overseeing process validation in a cGMP environment, coordinating multiple validation projects, and assisting with regulatory filings. Ideal candidates will have a technical degree, 8+ years of experience in a regulated environment, and strong communication skills. The company fosters an inclusive workplace and is committed to employee growth and innovation, ensuring compliance with the highest standards in drug manufacturing.