Job description
Role Overview
We are seeking a Project Engineer MFG to support a key client in the pharmaceutical manufacturing sector. The successful candidate will lead and support Manufacturing (MFG) projects, with a focus on CIP (Cleaning in Place) and SIP (Sterilization in Place) systems, cleanroom revamping, and the implementation of new production equipment.
This is a hands-on technical role requiring strong engineering expertise, project management skills, and deep knowledge of GMP environments. The engineer will ensure seamless integration of new systems while maintaining compliance with regulatory standards (EU GMP, FDA, etc.).
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Key Responsibilities
* Take the lead on CIP/SIP system support and optimization, including troubleshooting, performance validation, and process improvements.
* Lead cleanroom revamping projects, from concept to commissioning, ensuring compliance with ISO 14644 and GMP standards.
* Manage the implementation of new production equipment, including technical specifications, FAT/SAT, installation, and qualification (IQ/OQ/PQ).
* Coordinate with internal teams (Engineering, Validation, QA, Production) and external vendors (suppliers, contractors).
* Develop and review engineering documentation: P&IDs, URS, FDS, risk assessments (FMEA), and change controls.
* Ensure all projects adhere to GMP, safety, and environmental regulations.
* Support digital transformation initiatives (Industry 4.0, MES integration) where applicable.
* Provide technical training to operations and maintenance teams.
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Candidate Profile
* Education: Bachelor’s or Master’s degree in Mechanical, Chemical, Pharmaceutical, or Industrial Engineering.
* Experience: 5+ years in pharmaceutical manufacturing or engineering, with proven experience in CIP/SIP systems, cleanroom design/revamping, and equipment implementation.
* Technical Skills:
o Strong knowledge of GMP, FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
o Experience with validation protocols (IQ/OQ/PQ) and change control processes.
o Familiarity with HVAC, utilities, and sterile manufacturing environments.
o Proficiency in AutoCAD, 3D modeling, or project management tools (MS Project, Primavera) is a plus.
* Soft Skills: Leadership, autonomy, problem-solving, and excellent communication in English and Spanish (C1/C2 level).
* Certifications (preferred): PMP, Lean Six Sigma, or equivalent.
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Why Join Amaris with MANTU GROUP IBERIA?
* Be part of a high-impact project in a top-tier pharmaceutical environment.
* Work with cutting-edge technologies and global industry leaders.
* Benefit from career development, training, and visibility within the Amaris and MANTU ecosystem.
* Competitive daily rate or salary, depending on profile and experience.
* Flexible working conditions and professional support from MANTU’s Talent Acquisition and HR teams
Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees.
Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions.
International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe.