Validation Engineer

Cipla USA; Fall River (MA); On-site; USD 65,000 - 95,000; Full time

Job summary

An established industry player is seeking a Validation Engineer to ensure compliance and operational success in a pharmaceutical setting. This role involves designing protocols, maintaining equipment, and collaborating with cross-functional teams to uphold stringent quality standards. The ideal candidate will have a strong background in engineering, particularly in validation processes and PLC programming, and be adept at troubleshooting complex systems. Join a dynamic team dedicated to improving healthcare accessibility through high-quality medicines. This position offers an exciting opportunity to contribute to innovative projects in a fast-paced environment.

Qualifications

• Minimum 2 years experience in pharmaceutical machinery.
• Strong understanding of cGMP and validation protocols.
• Proficiency in troubleshooting and programming PLCs.

Responsibilities

• Design and approve protocols for pharmaceutical equipment.
• Maintain compliance with cGMP and regulatory requirements.
• Troubleshoot and maintain manufacturing equipment.

Skills

PLC Programming

Troubleshooting

Validation Processes

Electrical Engineering

Communication Skills

Project Management

Education

Bachelor's degree in Engineering

Master of Science in Electrical Engineering

Tools

E-designer

Cadence Virtuoso

HSPICE

ModelSim

Eclipse

PSpice

Matlab

AutoCAD

Job description

Job Title

Validation Engineer

FLSA Classification

Professional, Exempt

Work Location

Fall River, MA

Work Hours

General Shift: 8:30AM – 5:00PM (may vary based on business needs)

Reports To

Engineering Supervisor

Compensation Range

$65,000 - 95,000

Purpose

The content and statements documented in this job description are designed to describe the general nature and level of work as well as provide a basic understanding of the role, responsibilities, and expectations of the person assigned to perform the job.

Scope

Invagen Pharmaceuticals is searching for experienced candidates for the position of Validation Engineer. The Validation Engineer is responsible for performing validation activities and reviewing specifications for facilities, utilities, manufacturing, and laboratory equipment in a pharmaceutical setting with FDA regulations, Quality Management systems, cGMP practices, and 21CFR part 11 (Electronic Records and Signature). This position reports to the Site Engineering Lead and partners with cross functional team members to ensure compliance and operational success through user-focused documentation at InvaGen Pharmaceuticals, Inc, Fall River, MA.

The job duties for this position include but are not limited to the following:

• Design, review, and approve protocols for equipment and processes to produce pharmaceutical drug products meeting internal, external, and regulatory guidelines.
• Maintain facility as per cGMP and regulatory requirements.
• Introduce new SOPs, equipment, and instruments to improve the work environment from safety and quality perspectives by working closely with the Quality Assurance team.
• Compile and maintain records of validation documentation and electrical schematics, installed equipment, installation, or operational problems, corrective, and preventive actions.
• Programming, troubleshooting, and modifying PLC programs for optimal efficiency and operation of production machinery.
• Review the Design, Installation, Operational, and Product qualification of operational machinery.
• Assist in operations, validation, and electrical engineering plans to ensure adherence to design specifications and compliance with electrical codes and standards.
• Handle troubleshooting, preventive, and breakdown maintenance of manufacturing equipment for encapsulation, granulation, compression, coating, and packaging operations.
• Manage quarterly preventive maintenance and breakdowns of facility equipment including HVAC, boiler, chiller, air compressor, and electrical panels.
• Work closely with Quality Assurance and Validation Engineering teams to complete qualifications timely.
• Coordinate with external electrical/instrumentation service agencies on system upgrades and troubleshooting errors and breakdowns.
• Ensure all process improvement projects are completed on time and within budget.
• Diagnose, test, and analyze the performance of electrical components, assemblies, or systems. Troubleshoot existing systems for issues affecting operations.
• Drive continuous improvement activities supporting customer corrective actions, internal corrective/preventive actions, error-proofing, and process improvements.
• Develop and maintain schedules for all assigned projects.
• Other duties as assigned.

  Education and Experience

  • Bachelor’s degree in Engineering or related field from an accredited institution.
  • Master of Science degree in Electrical Engineering preferred.
  • Minimum 2 years experience in installing, testing, maintaining, and repairing pharmaceutical or biomedical machinery.
  • Strong understanding of Equipment and Facilities Qualification and Validation processes and protocols.
  • Knowledge in troubleshooting and fault finding in PCB, on-site repairs, and maintenance of process or utility equipment.
  • Experience programming, modifying, troubleshooting, and testing PLCs for pharmaceutical process machines.
  • Proficiency with PLC programming and troubleshooting.
  • Proficiency with tools like E-designer, Cadence Virtuoso, HSPICE, ModelSim, Eclipse, PSpice, Matlab, AutoCAD, Windows OS.

  Technical Knowledge and Computer Skills

  • Excellent communication skills, drive, and sense of urgency.
  • Proficient in Microsoft Office Suite.
  • Ability to follow SOPs, cGMP, and legal regulations.
  • High energy, capable of managing multiple projects in a fast-paced environment.
  • Self-starter with the ability to work independently and within a team.
  • Strong technical troubleshooting skills in manufacturing disciplines.
  • Knowledge of pharmaceutical manufacturing and documentation.
  • Experience in inhalation products (MDI) is a plus.

  Professional and Behavioral Competencies

  • Proficient in English communication.
  • Ability to analyze complex data sets.
  • Knowledge of GMP and documentation practices preferred.
  • Effective reading, writing, and communication skills.
  • Self-motivated, adaptable to changing environments, and capable of handling multiple tasks.

  Work Schedule and Other Position Information

  • Willing to work in a pharmaceutical manufacturing setting.
  • Open to working any shift (first, second, or third) based on business needs.
  • Willing to work some weekends as required.
  • Relocation negotiable.
  • No remote work or employment sponsorship available.

  About the Company

  Cipla is a leading global pharmaceutical company committed to high-quality medicines. We value our employees as our greatest assets and strive to make healthcare accessible worldwide. Our focus is on affordable, high-quality medicines with strict quality standards.

  About InvaGen Pharmaceuticals

  A Cipla subsidiary, InvaGen develops, manufactures, and distributes generic medicines across various therapeutic areas. Founded in 2003, it operates in New York and is part of Cipla since 2016.

  EEO Statement

  Cipla is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, age, sex, sexual orientation, gender identity, religion, national origin, genetic information, disability, or veteran status.