Senior Validation Engineer

4 weeks ago

Denver, United States Global Life Science Hub Full time
Job DescriptionJob Description

Global Life Science Hub is partnered with a niche, specialist biopharmaceutical company offering next-generation drug delivery technologies and an advanced pipeline of oral and biosimilar drugs. With 2 FDA approvals and new in-house manufacturing capabilities, they are primed to triple their production into 2025 to improve patient outcomes through innovative drug delivery technologies and therapeutic solutions.

The Validation Engineer will play a pivotal role in ensuring the efficiency, compliance and reliability of critical systems and processes within the organisation. The appointed candidate will be tasked with developing and executing validation protocols, encompassing a broad spectrum of other responsibilities.

Responsibilities:

  • Develop protocols for Equipment/Facility/Utility and Instrument Qualification (first in kind) and create Validation/Qualification Policies.
  • Initiate Change Controls independently, providing validation assessments and necessary remediation plans for systems/equipment/components.
  • Create Commissioning and Qualification Plans.
  • Develop URS, FS, DQ documents, and qualification protocols (IQ/OQ/PQ) ensuring compliance with relevant regulatory standards and guidelines.
  • Participate in Risk-Based evaluations, utilizing Risk Assessment Methods/tools and contributing technical insights during FMEA processes.
  • Lead discussions and offer guidance to personnel during risk assessments.
  • Ensure adherence to Quality Risk Management (Q9) principles.
  • Assure Compliance with applicable Regulations.
  • Evaluate, document, and conduct investigations related to qualifications failures.
  • Author Summary Reports, events, and relevant protocol amendments.
  • Execute protocols and/or provide support during their execution.
  • Track and successfully complete all qualification items.
  • Conduct GAP analysis and provide recommendations for existing qualifications.
  • Ability to thrive in a fast-paced, team-oriented environment.
  • Demonstrate technical problem-solving abilities, manage multiple priorities, apply logical and analytical reasoning, possess technical writing skills, and exhibit a proactive approach to self-training.
  • Possess potential to manage engineering projects from design through qualification, based on individual experience and skill set.
  • Adapt work schedules to perform required qualification activities, which may include overtime, overnight, or weekend work.

Requirements:

  • BS or MS Degree in a related Engineering field.
  • Minimum 4 years of experience in automated systems; project management experience is advantageous.
  • At least 2 years' experience in commissioning, validation, and qualification of Equipment/Facilities/Utilities and Processes using a Risk-Based approach.
  • Ability to thrive in a fast-paced environment, technical problem-solving skills, effective management of multiple priorities, ability to perform under pressure, quick and logical reasoning, technical reading interpretation, and self-training capabilities.

Apply:

The Global Life Science Hub are a niche Life Science headhunting firm. We place professionals across Europe and the US for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations.

If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies – www.glshub.com

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