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Validation Engineer

2+ years
Not Disclosed
10 Feb. 7, 2025
Job Description
Job Type: Full Time Education: B.Tech/B.E. Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

📢 Hiring: Validation Engineer

📍 Location: Fall River, MA
💼 Work Type: Permanent, Full-Time
Shift: General (8:30 AM – 5:00 PM, may vary)
💰 Compensation: $65,000 - $95,000

Job Purpose:

The Validation Engineer will be responsible for validation activities in a pharmaceutical setting, ensuring compliance with FDA regulations, cGMP practices, and 21CFR Part 11. This role supports operational success through user-focused documentation and process improvements.

Key Responsibilities:

✅ Design, review, and approve validation protocols for pharmaceutical manufacturing
✅ Ensure cGMP compliance and maintain facility standards
✅ Work with Quality Assurance to introduce new SOPs, equipment, and safety measures
✅ Troubleshoot PLC programs and optimize production machinery
✅ Oversee qualification processes for operational machinery
✅ Handle preventive and breakdown maintenance for key equipment (Encapsulation, Granulation, Coating, etc.)
✅ Collaborate with external service providers on system upgrades and troubleshooting
✅ Drive process improvements to enhance efficiency and compliance

Qualifications & Experience:

🎓 Bachelor’s degree in Engineering (Master’s in Electrical Engineering preferred)
📌 2+ years of experience in pharmaceutical or biomedical machinery maintenance
📌 Proficiency in PLC programming, troubleshooting, and CAD software
📌 Strong understanding of validation processes and GMP regulations

Technical & Behavioral Competencies:

✔ Strong analytical & troubleshooting skills
✔ Excellent communication & teamwork abilities
✔ Ability to handle multifaceted projects in a fast-paced environment
✔ Knowledge of pharmaceutical manufacturing & compliance standards

Additional Information:

🚫 No remote work available
📌 Relocation negotiable
📌 No employment sponsorship or work visas
📌 Weekend shifts may be required as per business needs

About Cipla & InvaGen Pharmaceuticals:

Cipla is a global leader in high-quality generic and branded medicines, committed to delivering world-class healthcare solutions. InvaGen Pharmaceuticals, a Cipla subsidiary, focuses on manufacturing and distributing generic prescription medicines across multiple therapeutic areas.

💡 Be part of a global pharmaceutical leader committed to excellence!