Engineering-Validation Specialist

1 week ago

Mid Devon Devon, United Kingdom Barrington James Limited Full time

Location: Denmark (Hybrid)
Join a leading pharmaceutical company in Denmark dedicated to advancing biologics manufacturing. We are committed to innovation and excellence in the development of life-changing therapies. As a Validation Specialist, you will play a vital role in ensuring the quality and compliance of our biologics manufacturing processes.
Develop and execute validation protocols for equipment, processes, and systems related to biologics manufacturing.
# Perform qualification and validation activities in accordance with regulatory requirements (e.g., FDA, EMA) and company policies.
# Collaborate cross-functionally with manufacturing, quality, and regulatory teams to support validation activities and ensure alignment with project timelines.
# Lead risk assessments and provide recommendations for mitigating risks associated with manufacturing processes.
# Support technology transfer activities from development to manufacturing.

Bachelor's or Master's degree in Pharmaceutical Sciences, Engineering, or related field.
Experience: Minimum of 6 years of experience in validation within the pharmaceutical or biotechnology industry, with specific experience in biologics manufacturing preferred.
Skills: Strong understanding of regulatory requirements and guidelines (e.g., GMP, ICH) related to validation in the pharmaceutical industry. Experience with validation software systems (e.g., Languages: Fluent in English; knowledge of Danish is advantageous but not required.

Opportunity to be at the forefront of biologics manufacturing, contributing to the development of life-changing therapies.
Collaborative and dynamic work environment with opportunities for professional growth and development.
Competitive compensation package with benefits, including health insurance, retirement plans, and more.
Located in Denmark, a country known for its high quality of life, excellent healthcare system, and vibrant culture.
If you are passionate about validation in biologics manufacturing and eager to make a difference, we encourage you to apply for this exciting opportunity. Join us in our mission to advance pharmaceutical innovation through excellence in biologics manufacturing. LI-CH3 #LI-Hybrid
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