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Validation Engineer

Cipla
2+ years
Not Disclosed
Massachusetts, United States
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

πŸ“’ Hiring: Validation Engineer

πŸ“ Location: Fall River, MA
πŸ’Ό Work Type: Permanent, Full-Time
⏰ Shift: General (8:30 AM – 5:00 PM, may vary)
πŸ’° 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:

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

Qualifications & Experience:

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

Technical & Behavioral Competencies:

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

Additional Information:

🚫 No remote work available
πŸ“Œ Relocation negotiable
πŸ“Œ No employment sponsorship or work visas
πŸ“Œ 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.

πŸ’‘ Be part of a global pharmaceutical leader committed to excellence!