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Amaris Consulting

Project Manager Parenterals - Pharma [F/M/X]

Beerse
Permanent Job
English, Dutch

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. 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!

Job description

Take your career to the next level with Amaris Consulting as a Project Manager Parenterals.
Become part of an international team, thrive in a global group with €800M turnover and 1,000+ clients worldwide, and an agile environment by planning the kickoff and follow up on projects. Join Amaris Consulting, where you can develop your potential and make a difference within the company.


WHAT WOULD YOU NEED? ✍️

  • Master’s degree in a technical field or equivalent through experience.
  • At least 5 years of proven experience in pharmaceutical engineering.
  • Solid knowledge of GMP environment and parenteral manufacturing equipment and processes (e.g., processors, fill-finish equipment, autoclaves, dry heat ovens, CIP/SIP systems, lyophilizers, nano-milling, temperature mapping).
  • Experience with qualification activities in the pharmaceutical sector and knowledge of GMP, GDP, and data integrity.
  • Good understanding of aseptic process simulation (e.g., surface decontamination, steam sterilization, dry heat sterilization & depyrogenation).
  • Experience in leading projects according to FPX methodology or equivalent.
  • Full professional command of Dutch and English (spoken and written).
  • Proficient in Microsoft Office tools (Excel, Word, Teams, MS Project, etc.).
  • Willingness to travel up to 20% for FATs.
  • Strong problem-solving, analytical, and organizational skills.
  • Ability to work independently and systematically.
  • Stress-resistant, flexible, and a team player with a strong quality and compliance mindset.

👉 WHAT WILL YOU DO? 👈

  • Lead and manage parenteral equipment projects from scope definition to execution and validation.
  • Organize and carry out project management tasks independently or within a team.
  • Act as a specialist/owner of parenteral equipment in multidisciplinary projects.
  • Draw up technical specifications and lead the tendering process for parenteral equipment.
  • Prepare, execute, and review qualification and validation protocols and reports.
  • Supervise risk analysis, GMP guidelines, and procedures.
  • Prepare, execute, and review aseptic process simulations, including media fill, PS, and revalidations.
  • Support troubleshooting and provide solutions for operational problems.
  • Organize project team, planning, and budget alignment.
  • Prepare and execute FAT, SAT, and commissioning activities.
  • Supervise construction work and manage life cycle documents (URS, risk assessments, IOPQ, validation protocols, etc.).
  • Document quality incidents, deviations, and follow-up actions in accordance with protocols.
  • Define and implement preventive measures for deviations.
  • Propose and defend qualification approaches to QA and participate in improvement initiatives and gap assessments.
  • Manage CCs and CAPAs in the COMET system, including initiation, follow-up, and deregistration.

🚀 WHY US? 🚀

Join our dynamic team of talented individuals and experience a world of growth and opportunities.

Here's what we offer:

  • Grow rapidly with a tailored career path and salary evaluation.
  • 70% of our senior leaders started at entry level.
  • Enhance your skills through our Tech Academy catalog, Udemy E-learning Platform, Languages Sessions, webinars, and workshops.
  • Take charge of your training with an annual personal budget and company-paid certifications.
  • Enjoy flexible policies, remote work options, and fantastic social benefits like transit and restaurant tickets, kindergarten support, and private health insurance.
  • Benefit from our WeCare program, supporting employees in critical situations.
  • Unleash your full potential, both professionally and personally.

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.

Interested in this job?

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