Commissioning Qualification Validation Engineer

The CQV Engineer shall perform commissioning and qualification of bio/pharmaceutical equipment, including any or all of systems for medical/buffer preparation, fermentation, cell harvest, ultra-filtration, chromatography, CIP, SIP, TFF, Chromatography, Centrifuge Systems.

Responsibilities

• Develop risk assessment, system impact assessments, validation plans, protocols and reports that support the qualification and validation of systems.
• Develop and execute Commissioning and validation Protocols for Bioprocess Equipment’s
• Preparation of System Boundaries, SLIA, CLIA, QRA, Facility Risk Assessments
• Review, analyze and interpret system performance data for completed validation and prepare final report packages by summarizing the data.
• Investigate deviations, write investigation reports and create summary reports.
• Promote cGMP and regulatory compliance into assigned projects.
• Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Hands on Experience with Biopharma Process Equipments.

Qualifications & Other requirements

• BS degree or higher in chemical engineering or a related engineering or scientific discipline, or significant related experience
• 4-10 years in validation, quality systems, operations, engineering or any combination thereof.
• Experience in multiple GMP validation disciplines with advanced technical knowledge.
• Validation experience using , traditional, risk based, Hybrid approach.
• Knowledge of Validation Lifecycle approach (URS, FRS, FAT/SAT, Commissioning IQ,OQ,& PQ Protocols, etc.) guidelines, international regulatory requirements and standards and other in.
• Experience working with Documentum or Maximo a plus.
• Experience interacting with or creating material for representatives of regulatory agencies and executive level staff.
• Experience with investigations into manufacturing deviations and determination of product impact potential, root cause and corrective actions.
• Strong verbal and written communication skills; excellent organizational and time utilization skills
• Ability to work independently and within project teams.
• Industry experience related to cGMP drug manufacturing, validation, and chemical process design
• Strong computer knowledge including Microsoft Office products

Since 1993, Hyde E+C has worked as an integral part of project teams for clients and equipment vendors in the pharmaceutical and biopharmaceutical industries, resulting in the successful construction, commissioning and validation of facilities and equipment. As a member of the Hyde team, you will be responsible for providing state-of-the-art custom solutions to leaders in our industry. As we continue to grow our operations globally, we strive to hire the best talent—men and women dedicated to quality and innovation. We offer a collaborative culture, challenging projects, and excellent compensation and benefits.

You will find the following values reflected in our company:

• Family
• Integrity
• Respect
• Wisdom
• Adventure

Hyde Engineering + Consulting is an equal opportunity, affirmative action employer.

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