Validation and QA Specialist 1

Merck Life Science; Bengaluru; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Merck Life Science in Bengaluru seeks a senior validation professional to lead comprehensive validation activities across equipment, utilities, and manufacturing processes in a cGMP setting. You will develop and execute IQ/OQ/PQ protocols, coordinate cleanroom qualification, and maintain documentation aligned with GAMP 5, FDA 21 CFR Part 11, and ISO 9001.

You will drive CAPAs, risk assessments, and root-cause analyses, collaborating with cross-functional teams to ensure timely closure of actions

Qualifications

• IQ/OQ/PQ lifecycle knowledge and hands-on experience.
• FMEA and risk assessment proficiency.
• Understanding of cGMP, GAMP 5, and ISO 9001 requirements.
• Strong documentation and change control skills.

Responsibilities

• Identify, plan, and implement validation across equipment, utilities, and processes in a cGMP facility.
• Prepare, execute, and manage IQ/OQ/PQ protocols across systems and facilities.
• Coordinate cleanroom qualification and maintain validation documentation per regulatory standards.
• Lead CAPAs, risk assessments, trend analyses, and QMS improvements; drive timely closures.
• Serve as site validation owner; support tech transfer, audits, and regulatory inspections.

Skills

IQ/OQ/PQ lifecycle

FMEA

GAMP 5

ISO 9001

HVAC principles

Root cause analysis

Audits & inspections

Regulatory awareness

Education

Bachelor's/Master's in Biotechnology/Engineering or Pharma

Job description

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.
• Demonstrated hands‑on experience in preparing, executing, and managing IQ/OQ/PQ protocols across equipment, systems, facilities, utilities, and manufacturing or testing processes in a cGMP environment.
• 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 9001 and organizational 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 site validation owner, quality face to customers; 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.
• Candidates must have direct implementation experience and ownership of validation activities.

Who You Are

• Education: Degree in Biotechnology/Engineering or master’s degree pharmaceuticals.
• Experience: Minimum 6 years’ total experience, with at least 5 years in a 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.
• Communication and collaboration skills will be evaluated as key selection criteria alongside technical expertise, including the ability to influence cross‑functional teams, lead discussions, and drive timely resolution of validation‑related issues.

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!