Validation and QA Specialist 1

Biopharma Careers; Bengaluru; On-site; INR 2,600,000 - 4,000,000; Full time

Job summary

Biopharma Careers seeks a seasoned Validation Lead for a cGMP facility in Bengaluru, India. The role demands hands-on IQ/OQ/PQ lifecycle management across equipment, utilities, and production processes, with a focus on compliance and steady validation deliverables.

You will own validation activities, drive risk assessments, coordinate audits, and support technology transfer. The ideal candidate has 5+ years in validation and strong knowledge of GMP standards, GAMP5, and ISO 9001, with hands-on

Qualifications

• Experience in IQ/OQ/PQ lifecycle for equipment and processes.
• Strong knowledge of GMP, GAMP 5, ISO 9001 and regulatory expectations.
• Ability to lead audits, CAPAs, and cross-functional teams.

Responsibilities

• Identify, plan, and implement validation requirements across equipment, instruments, utilities, and facilities.
• Prepare, execute, and manage IQ/OQ/PQ protocols in a cGMP environment.
• Coordinate cleanroom qualification and maintain the Validation Master Plan (VMP).
• Review validation docs, SOPs, and ensure controlled documentation.
• Lead audits/regulatory inspections and drive timely CAPA closure.
• Collaborate with Production, Maintenance, and cross-functional teams on validation deliverables.

Skills

Validation

Quality systems

Regulatory compliance

Cross-functional collaboration

Process improvement

Education

Degree in Biotechnology/Engineering or master's degree pharmaceuticals

Tools

GAMP 5

ISO 9001

FDA 21 CFR Part 11

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.

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.

Candidates must have direct implementation experience and ownership of validation activities.

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!