Position: Validation Engineer, Commissioning & Qualification — Biotech/Pharma
This position 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 and purified water, WFI, and clean steam make-up and distribution.
- 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 of process,clean utility, black utility and HVAC systems
- Preparation of System Boundaries, SLIA, CLIA, QRA,FRA, Facility Risk Assessments
- Develop moderate to highly complex protocols for validation projects using a risk based approach that meets regulatory requirements and industry practices.
- 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.
Qualifications & Other requirements
- BS/MS in Engineering or Sciences.
- 5-10 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
- Valid International passport without any legal obligations in terms of obtaining visa and should be willing to travel
Note: Every effort has been made to identify the essential responsibilities of this position. However, it
in no way states or implies that these are the only duties, nor is it intended to be such a listing of the skills and abilities required to do the job. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or is an essential function of the position.