Validation and QA Specialist 1

Merck Life Science

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

Your Role

Identify, plan, and implement validation requirements across equipment, instruments, utilities, and manufacturing/testing processes in a cGMP greenfield facility.
Prepare and execute IQ/OQ/PQ protocols; coordinate and support cleanroom qualification, facility and utility qualification activities; create and govern the Validation Master Plan (VMP); review, approve, and maintain validation protocols, SOPs, and technical documentation in a controlled, compliant manner (cGMP, GAMP 5, FDA 21 CFR Part 11, ISO 9001).
Identify and assess validation changes, deviations, and CAPAs; ensure remediation and closure of compliance actions; conduct risk assessments (FMEA, impact assessments); perform trend analysis of non-conformances and data reviews; ensure QMS conforms to ISO 9001a and organisational policies; lead audits and regulatory inspections; drive root cause analysis and timely closure of corrective actions; collaborate with cross-functional teams to drive validation deliverables.
Acts as the quality face to customers for products; performs process audits to identify gaps and implement corrective actions; supports technology transfer and global projects; stays current with industry regulations and trends; supports EHS/OSHA as required; operates in a multi-cultural, multi-time-zone environment; demonstrates strong networking and problem-solving skills to influence across organizational levels.
Strategic objective: build a strong Validation Team to enable successful product transfers; works closely with Production, Maintenance, and cross-functional teams; engages with suppliers and service providers.

Who You Are

Education: Degree in Biotechnology or Master’s degree in Life Science/pharmaceuticals; related life-science/engineering background acceptable depending on the role.
Experience: Minimum 6 years’ total experience, with at least 5 years in a quality validation role; experience in reputed pharma industries or research institutes; prior involvement in projects, facilities startups, and technology transfer preferred.
Deep knowledge of IQ/OQ/PQ lifecycle; proficiency in FMEA and impact assessment; understanding HVAC principles; strong problem-solving, analytical, and communication skills; ability to lead change and build cross-functional relation

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!