Project Engineer - Change Control

Who are we? Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 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 7,600 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. Heres 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 candidates shoes to ensure they have the best possible experience.
We look forward to meeting you! Job description

Key Duties & Responsibilities:

• Develop and maintain change control procedures in accordance with regulatory requirements (e.g., FDA, EMA) and company standards.
• Manage the change control process from initiation through completion, ensuring timely review, approval, and implementation of changes.
• Collaborate with internal stakeholders (Quality Assurance, Regulatory Affairs, Manufacturing, Engineering) to assess change impact and develop appropriate mitigation strategies.
• Lead change control meetings and discussions to facilitate decision-making and ensure alignment among stakeholders.
• Evaluate proposed changes for feasibility, risks, and potential impact on product quality, compliance, and project timelines.
• Maintain accurate and up-to-date documentation related to change control activities, including change requests, assessments, and approvals.
• Monitor and track the status of change controls, ensuring timely closure and resolution of outstanding items.
• Provide guidance and support to project teams on change control requirements and best practices.
• Conduct periodic reviews and assessments of the change control process to identify areas for improvement and implement enhancements as needed.
• Participate in regulatory inspections and audits related to change control processes.