Title:Process Engineer

Location:Madurai Manufacturing

Family:Engineering The Process Engineer is responsible for providing technical leadership and subject matter expertise in process validation, cleaning validation, packaging validation, equipment qualification, manufacturing process optimization, and commercialization activities within pharmaceutical and nutraceutical manufacturing operations.

The role drives process robustness, product quality, regulatory compliance, operational excellence, and lifecycle management through validation, equipment qualification, process monitoring, troubleshooting, risk management, and continuous improvement initiatives. The position serves as the technical owner for manufacturing and packaging process performance and supports successful transfer of validated processes into routine commercial operations.

The role works closely with Manufacturing, Packaging, Quality Assurance, Quality Control, Supply Chain, Project Engineering, EHS, Procurement, Regulatory Affairs, and R&D; functions to ensure safe, compliant, and efficient manufacturing operations.

PRIMARY RESPONSIBILITIES

Validation, Qualification & CQV

- Lead and execute CQV, IQ, OQ, PQ, process validation, cleaning validation, packaging validation, and hold-time studies.
- Develop validation strategies, protocols, reports, and qualification documentation.
- Support qualification of facilities, utilities, instrumentation, automation, and computerized systems.
- Apply risk-based validation principles and ensure compliance with GMP and Data Integrity requirements.

Manufacturing & Packaging Process Engineering

- Provide technical ownership of manufacturing and packaging processes throughout the product lifecycle.
- Establish and maintain process centerlines, critical process parameters, and process controls.
- Support formulation, encapsulation, coating, drying, blending, and packaging operations through engineering studies and performance assessments.
- Evaluate packaging equipment performance, including feeder systems, vibratory flow, counting accuracy, occupancy detection systems, and bottle filling operations.
- Support scale-up, commercialization, and implementation of new technologies and processes.

Process Monitoring & Technical Studies

- Design and execute engineering studies, DOE, hold-time studies, temperature and humidity mapping, and process capability assessments.
- Analyze manufacturing, validation, and packaging data using statistical tools to identify improvement opportunities.
- Develop process monitoring systems, dashboards, and performance metrics to ensure process robustness and consistency.





Troubleshooting & Investigations

- Act as the primary technical resource for manufacturing and packaging process issues.
- Lead root cause investigations, deviation assessments, and CAPA implementation.
- Provide shop-floor support to resolve process, equipment, quality, and productivity-related challenges.

Documentation, Compliance & Change Management

- Develop, review, and maintain validation documentation, SOPs, Manufacturing Instructions (MI), Standard Work Instructions, and process specifications.
- Support change controls, risk assessments, deviations, and documentation updates arising from process improvements and validation outcomes.
- Ensure compliance with GMP, Good Documentation Practices, and regulatory requirements.

Commercialization & Lifecycle Management

- Support new product introduction (NPI), technology transfer, and commercial validation activities.
- Translate validation and optimization learnings into sustainable manufacturing practices.
- Develop manufacturing instructions and process control strategies for commercial production.

Continuous Improvement & Manufacturing Excellence

- Lead Lean, Six Sigma, and data-driven improvement initiatives to enhance quality, yield, throughput, and operational efficiency.
- Drive cost reduction, waste elimination, cycle-time reduction, and process optimization projects.
- Benchmark and implement industry best practices to strengthen manufacturing performance.

Audit & Regulatory Support

- Support internal, customer, and regulatory audits and inspections.
- Provide technical justifications, validation evidence, and compliance documentation.
- Ensure validation and qualification programs remain inspection-ready at all times.

OTHER JOB RESPONSIBILITIES

Product Lifecycle Management

- Own execution of Qualification, Validation, and Commercialization activities for assigned manufacturing areas.
- Establish process monitoring systems and centerline controls.
- Develop Manufacturing Instructions and process control strategies.
- Support process scalability and sustained process performance throughout the product lifecycle.

Manufacturing Support

- Support routine manufacturing operations through troubleshooting and technical guidance.




- Monitor adherence to process centerlines and validated operating ranges.
- Provide technical coaching and training to manufacturing personnel.

Systems Development

- Train stakeholders prior to protocol execution.
- Develop training materials related to process controls, validation activities, and operating procedures.
- Support competency development of operations personnel regarding process equipment and validated processes.
- Requires basic knowledge of principles and practices of area of specialty.
- Assignments designed to develop professional work knowledge and abilities.
- Develops solutions to routine technical problems of limited scope using application of basic technical principles, theories and concepts.
- Work mostly focused on tasks, with supporting role on projects and programs.
- Work direction given in tasks, following detailed instructions with review of work by peers or upline and reliance on upline for problem resolution.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES AND/OR RELATED EXPERIENCE Education Degree : B.Tech./B.Pharm (Engineering/Pharmacy )

EXPERIENCE : 4-6 YEARS

Certification(s) / License(s)

Certified Quality Auditor, Exposure to USFDA audits, Six Sigma Green Belt.

Required Knowledge, Skills, Abilities and/or Related Experience:

- Must have excellent verbal and written communication skills.
- Must be able to effectively communicate with large groups and work collaboratively.
- Must have legible handwriting, and the ability to perform positive doc practices and maintain data integrity.
- Must be detail oriented, capable of following instructions precisely, and capable of accurately transcribing detailed information.
- Must be capable of accurately performing mathematical operations and routinely making numerical entries without errors.
- Must be organized and have the ability to ability to coordinate multiple activities.
- Must be able to work in a methodical and organized fashion and maintain mental focus to ensure efficient and accurate completion of individual tasks.
- Proficiency in computer skills including data entry, report writing, and data analysis using Microsoft Excel, and Microsoft Word is required.
- Knowledge of the practical application of engineering science and technology. This includes applying principles, techniques, procedures, and equipment to the design and production of various goods and services.
- Manufacturing operations management experience. Possesses broad comprehensive knowledge of technologies in pharmaceutical, dietary supplement, and consumer product manufacturing and packaging industries.

📌 Process Engineer (Madurai)
🏢 Amway
📍 Madurai