Validation Engineer

at  Amaris

Belgium, , Belgium -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate22 Jul, 2024Not Specified28 Apr, 20247 year(s) or aboveGood communication skillsNoNo
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Description:

Job description
Job Description
We are seeking a highly skilled and experienced Validation Engineer at Amaris Consulting. This is an opportunity to join an integrated project team where you will drive the Performance Qualification (PQ) preparation and execution activities of the project. The role ensures that all tasks are completed in accordance with system requirements, specifications, quality attributes and project procedures/guidelines.
Scope: Clean Utilities (water, gas, air, steam, decontamination station)
Facility Environmental Monitoring (classified area PQ)
Temperature control units management (fridge, freezer, incubator etc.)
Cleaning process oversight including Parts Washer cleaning cycle
Sterilisation process management including Autoclave sterilisation cycle
PQ strategy/protocol drafting following approved PQ VMP guidelines
Assisting in Quality Risk Assessment development for PQ
PQ verification deliverables driving; protocol execution; deviation investigation and resolution coordination
C&Q status planning tracking & reporting along with risk/issues identification
This position is based in Belgium under an Undetermined Duration Contract type job arrangement.
About You
The ideal candidate for this role would be someone who has 7-10 years of experience as a Validation Engineer or similar roles within the industry. As an experienced Validation Engineer/PQ Specialist; you will act as C&Q Subject Matter Expert providing guidance to stakeholders on all aspects related to performance qualification from strategy development to summary report approval ensuring compliance with cGMP regulations.
Proven experience in driving PQ preparation and execution activities
Expertise in Clean Utilities, Facility Environmental Monitoring, Temperature control units management
Demonstrated ability to draft PQ strategy/protocol(s) following approved guidelines
Experience with Quality Risk Assessment development for PQ
Adept at managing deviation investigation and resolution during execution activities
Familiarity with change controls related to technical modifications approval coordination
We are looking for a proactive individual who can take appropriate corrective actions as required to ensure deadlines and milestones are achieved. You should be able to establish and monitor validation KPIs while also reviewing handovers of equipment/systems from suppliers or other project stakeholders.
What can you expect?
Amaris Consulting is proud to be an equal-opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability or other characteristics.
Who are we?
Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7500 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.
At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here’s what our recruitment process looks like:
Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!
Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!
Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.
As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate’s shoes to ensure they have the best possible experience.
We look forward to meeting you

Responsibilities:

Please refer the Job description for details


REQUIREMENT SUMMARY

Min:7.0Max:10.0 year(s)

Information Technology/IT

IT Software - Other

Software Engineering

Graduate

Proficient

1

Belgium, Belgium