Validation Engineer

Validation Engineer

Fall River, MA, United States

About the Job

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:

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 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, ModelSim, 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 and as part of a team.
  • Experience in Inhalation products (MDI) is a plus.

  Professional and Behavioral Competencies:

  Proficiently speak English as a first or second language

  Knowledge of good manufacturing practices and good documentation practices preferred.

  • Ability to read, write and communicate effectively.
  • Self-motivated, with the ability to work in a fast-paced manufacturing environment and handle multiple tasks simultaneously.
  • Position requires flexibility to quickly adapt to changing work environment and schedules.

  Work Schedule and Other Position Information:

  Must be willing to work in a pharmaceutical manufacturing setting.

  Must be willing and able to work any assigned shift ranging from first, second, or third shift. Work schedule may be Monday to Friday, Tuesday to Saturday, or some combination thereof based on business needs.

  Must be willing to work some weekends based on business needs as required by management.

  Relocation negotiable.

  No remote work available.

  No employment sponsorship or work visas.

  Global Company:

  Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in Indias pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world.

  Cipla employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare. The company believes that our biggest assets are the employees who lead us to prosperity and growth in the future. Driven by the vision, none shall be denied, Ciplas focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.

  CIPLA NEW YORK (INVAGEN PHARMACEUTICALS, INC.)

  About InvaGen Pharmaceuticals, a Cipla subsidiary InvaGen Pharmaceuticals, Inc. is engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. As of February 18, 2016, InvaGen Pharmaceuticals, Inc. operates as a subsidiary of Cipla (EU) Limited.

  EEO Statement:

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

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