Process Validation Engineer - Pharmaceutical
Actively Reviewing the ApplicationsNovintiX
India, Tamil Nadu, Coimbatore
Internship
On-site
Posted 3 weeks ago
•
Apply by June 16, 2026
Job Description
Job Title: Senior Process Validation Engineer – Pharmaceutical
Experience: 5-8 Years
Industry: Pharmaceutical / Biopharmaceutical
Department: Manufacturing Science & Technology / Validation
Employment Type: Full-Time
Job Summary
We are looking for a highly experienced Process Validation Engineer to lead validation
activities for pharmaceutical manufacturing processes. The candidate will be
responsible for Process Performance Qualification (PPQ), cleaning validation,
process design, and continuous process monitoring to ensure regulatory compliance
and consistent product quality.
The ideal candidate will have strong experience in process validation lifecycle
management and regulatory requirements within the pharmaceutical industry.
Key Responsibilities
Experience: 5-8 Years
Industry: Pharmaceutical / Biopharmaceutical
Department: Manufacturing Science & Technology / Validation
Employment Type: Full-Time
Job Summary
We are looking for a highly experienced Process Validation Engineer to lead validation
activities for pharmaceutical manufacturing processes. The candidate will be
responsible for Process Performance Qualification (PPQ), cleaning validation,
process design, and continuous process monitoring to ensure regulatory compliance
and consistent product quality.
The ideal candidate will have strong experience in process validation lifecycle
management and regulatory requirements within the pharmaceutical industry.
Key Responsibilities
- Process Validation
- Plan, execute, and document Process Performance Qualification (PPQ)
- studies.
- Develop and review process validation protocols and reports.
- Ensure validated processes meet regulatory and internal quality standards.
- Cleaning Validation
- Develop and implement cleaning validation strategies for manufacturing
- equipment.
- Prepare cleaning validation protocols, sampling plans, and reports.
- Ensure compliance with regulatory expectations.
- Continuous Process Monitoring
- Implement continued process verification (CPV) programs.
- Monitor process performance and analyze trends.
- Support investigations and corrective actions for process deviations.
- Process Design & Improvement
- Support process design, scale-up, and technology transfer activities.
- Work with cross-functional teams including Manufacturing, QA, MSAT, and
- R&D.
- Identify opportunities for process optimization and efficiency improvements.
- Validation protocols and reports
- Prepare and maintain validation documentation including:
- Risk assessments
- Process validation master plans
- Ensure compliance with cGMP, FDA, EMA, and ICH regulatory requirements.
- Participate in internal and external audits.
- Bachelor’s or master’s degree in chemical engineering, Pharmaceutical
- Engineering, Biotechnology, or related field.
- 10–15 years of experience in pharmaceutical process validation.
- Strong experience in PPQ, process validation lifecycle, and cleaning
- validation.
- Knowledge of cGMP, regulatory guidelines, and validation standard
- Preferred Skills
- Experience in continuous process monitoring / CPV.
- Experience supporting regulatory inspections (USFDA / EMA / MHRA).
- Familiarity with risk management tools such as FMEA and Quality Risk
- Management.
- Strong analytical, documentation, and communication skills.
Required Skills
Communication
Engineering
Risk Management
Documentation
Compliance
Monitoring
Cleaning
Process Optimization
Quality Standards
Biotechnology
Chemical Engineering
Chemical
Validation
Risk assessments
Risk
FMEA
Verification
FDA
Pharmaceutical
CGMP
Management tools
Investigations
Process performance
Corrective Actions
Protocols
Quality Risk management
Process Validation
Cleaning validation
MHRA
Transfer
Scale-up
Technology Transfer
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