Validation Engineer

About the job Validation Engineer

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:
Site Lead Engineer

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:

Inva Gen 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 21

CFR 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 Inva Gen 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 requirement.
• Introduce new SOPs, equipment, and instruments to improve the work environment by safety and quality point of view by working closely with 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 optimum efficiency and ideal operation of production machineries.
• Review the Design, Installation, Operational and Product qualification of operations machineries.
• Assist in the operations, validation, and electrical engineering plans to ensure adherence to design specifications and compliance with applicable 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 which includes HVAC, Boiler, Chiller, Air Compressor and Electrical Panels.
• Work closely with Quality Assurance and Validation Engineering team to complete the qualification in timely manner.
• Work closely with external electrical/instrumentation service agencies on upgrading existing systems and troubleshoot 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 the existing systems for any issues which hampers the operations in any manner.
• Drives continuous improvement activities in support of customer corrective actions, internal corrective/preventive actions, error-proofing & general process improvement.
• Develop and maintain schedules for all projects assigned.
• Other duties as assigned.
  
  Education and Experience
• Bachelors degree in Engineering or related field from an accredited institution.
• Master of Science degree in Electrical Engineering preferred.
• Must have 2-year experience in installing, testing, maintaining and repairing pharmaceutical or Biomedical machinery.
• Excellent understanding of Equipment and Facilities Qualification and Validation processes and protocols
• Must have knowledge in troubleshooting and fault finding in PCB, on-site repairs and maintenance of any process or utility equipment.
• Must have experience programming, modifying, troubleshooting and testing PLCs for compression, encapsulation, granulation, packaging and coating process machines.
• Must be proficient with: PLC programming, troubleshooting.
• Must be proficient with E-designer, Cadence Virtuoso, HSPICE, Model Sim, Eclipse, PSpice, Matlab, AutoCAD, Windows OS.

Technical Knowledge and Computer Systems Skills

• Excellent communication skills, drive, and sense of urgency
• Excellent computer skills, specifically Microsoft Office Suite.
• Follow strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Manufacturing Practices (cGMP), complying with legal regulations, monitoring environment.

• High energy level, comfortable performing multifaceted projects in conjunction with day-to-day activities.
• Must have ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team-based environment.
• Strong technical & troubleshooting abilities in a variety of manufacturing disciplines including demonstrated expertise in a production environment.
• Knowledge of pharmaceutical manufacturing and related documents.
• Ability to work effectively both independently…