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.
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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.
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👉 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.
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🚀 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.