Job Description

Job description
About the job
Supports Validation activities related to validation of facility, equipment and utilities.
Support day-to-day Validation activities in accordance with approved Validation SOPs/Plan/Policies.
Develop & execute Validation Protocols and Reports, including supporting site discrepancies and deviations investigation/closure.
Collaborate with vendors and other Engineering functions to perform technical evaluation of the new equipment or modification, to develop appropriate protocol that will demonstrate that the equipment or modification meet the user or project requirements.
Participate in system design review to ensure compliance with user requirements, good engineering practice, validation requirements and regulatory standards.
Collaborate with other Engineering functions, End-User, and Quality team to ensure the Validation activities are completed as planned.
Review Engineering documents associated with commissioning and validation activities.
Participate in Site Validation Maintenance Program.
Participate in commissioning activities when required.
Support Change Implementation on site.
Support Customer/Agency Audits and Inspections as required.
Assist with the implementation of department training requirements.
Ad hoc tasks as and when assigned by supervisor/manager.
About you
Bachelor\xe2\x80\x99s degree/Diploma in science or engineering discipline.
Relevant work experience in Validation/Quality units in the pharmaceutical/biotech industry.
Prior experience in Kaye validator or temperature mapping.
Fair knowledge and experience of the practical and theoretical requirements of validation program in a GMP facility.
Team player, with a strong focus on safety, quality, and timelines.
Able to work independently.
Strong organizational skills.
Able to effectively prioritize and execute tasks in a fast-paced environment.
Strong written and oral communication skills.

Equal opportunity

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 \xe2\x80\x93 this is made possible by an international team of 6000 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\xe2\x80\x99re 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!