What are the responsibilities and job description for the Validation Manager position at WhiteCrow Research?
About WhiteCrow
We are global talent research, insight and pipelining specialists with offices in the UK, USA, Singapore, Malaysia, Hong Kong, Dubai, and India. Our international reach has helped us to understand and penetrate specialist markets at a global level. In addition to this, our service is also extended to complement our client’s in-house research.
About our client
Our client is a global injectables company headquartered in Bengaluru, India, with a strong presence across Asia, Europe, and the USA, and is expanding rapidly into new markets. The company focuses on developing value-added sterile injectables that address critical gaps in healthcare delivery.
By enhancing hospital workflows, reducing wastage of key resources, and improving operational efficiency, our client plays a vital role in supporting healthcare professionals. A robust and reliable supply chain further ensures consistent access to essential medications for patients worldwide.
As a Validation Manager, you will be responsible for...
- Serving as the site Validation SME, overseeing all validation activities, including process, cleaning, equipment, utility, and computer system validation.
- Owning and maintaining the Validation Master Plan (VMP), ensuring alignment with regulatory expectations, site activities, and company objectives.
- Developing, implementing, and maintaining the site validation lifecycle program, including process validation, performance qualification (PQ), and CPV.
- Leading validation planning and coordination efforts for new equipment, systems, and process changes in collaboration with Engineering, Manufacturing, and Quality.
- Managing validation project timelines and resource allocation, ensuring activities support commercial readiness and ongoing operations.
- Reviewing and approving validation protocols, reports, and risk assessments in compliance with FDA, EMA, ICH Q8-Q10, EU Annex 15, and company standards.
- Supporting and participating in cross-functional risk assessments (e.g., FMEA) related to qualification and validation efforts.
- Ensuring validation documentation is complete, accurate, and audit ready.
- Providing guidance and technical expertise during regulatory inspections, audits, and customer assessments.
- Developing and maintaining the site’s Continuous Process Verification (CPV) program to monitor validated state and process performance over time.
- Defining and monitoring KPIs for validation program effectiveness and drive improvements in validation efficiency and compliance.
- Training and mentoring staff on validation principles and procedures to build internal capability across departments.
- Ensuring change control, deviation management, and CAPA processes integrate appropriately with validation and qualification requirements.
Key Stakeholders:
Internal:
- Site Quality, Manufacturing, and Engineering Teams
- Technical Services, Supply Chain, and EHS
- Validation Analysts and Support Staff
- Corporate Validation and Quality Teams
External:
- Regulatory Agencies (FDA, EMA, etc.)
- Equipment and system vendors
- Contract testing laboratories
- Third-party auditors and certifying bodies
What you already have...
Qualifications / Experience:
- Bachelor’s degree in engineering, Life Sciences, Pharmacy, or related discipline; Master’s preferred
- Minimum 10-12 years of experience in pharmaceutical or biotechnology validation, with at least 3 years in a leadership or SME role
- Validation of sterile injectable equipment expertise required
- Strong knowledge of FDA cGMPs, ICH Q8–Q10, EU Annex 15, and validation best practices
- Experience with sterile injectable manufacturing, aseptic processes, utilities, and equipment qualification
- Experience with controlled substances and high-potency compounds preferred
- Proven experience supporting regulatory inspections and third-party audits
- Experience with commissioning, qualification, and validation in a startup (greenfield) or expansion environment preferred
Skills / Competencies:
- Strong technical writing and documentation review skills
- Ability to manage multiple projects and prioritize in a fast-paced environment
- Expertise in sterile systems, process validation, cleaning validation, and computer system validation
- Excellent cross-functional communication, influencing, and collaboration skills
- Strong analytical, risk-based decision-making, and problem-solving skills
- Leadership presence with ability to coach and mentor others in validation principles
- Commitment to data integrity, patient safety, and product quality