Validation Engineer

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 2024 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