Over de functie
As a Process Engineer at Fagron Sterile Services, you will play a crucial role in optimizing and enhancing manufacturing processes. Your primary focus will be the engineering liaison developing new processing, ensuring cGMP compliance, and driving efficiency improvements. You will be responsible for analyzing current processes, identifying areas for improvement, and implementing solutions that enhance productivity and quality. This position requires a good understanding of engineering principles, cGMP, and the ability to work collaboratively with cross-functional teams to achieve operational excellence.
Key Responsibilities
· Work with Director of Engineering designing, developing, and optimizing manufacturing processes, ensuring compliance with regulatory standards.
· Collaborate with NPD, quality assurance, and production teams to troubleshoot and resolve process-related issues.
· Prepare and maintain comprehensive documentation, including Standard Operating Procedures (SOPs).
· Monitor and analyze process performance data to identify areas for improvement and implement corrective actions.
· Ensure adherence to Good Manufacturing Practices (GMP) and other regulatory requirements.
· Conduct risk assessments and develop mitigation strategies to address potential compliance and quality issues.
· Provide training and support to manufacturing personnel on process operations and GMP compliance.
· Conduct process validation and equipment qualification to maintain product quality and consistency.
· Participate in regulatory inspections and audits, providing documentation and supporting evidence to demonstrate compliance with cGMP regulations.
· Contributor during semi-annual shutdowns
· Other projects and duties as required.
Maak het verschil
Basic Qualifications
· Bachelor’s degree in engineering or commensurate experience.
· Minimum of 3-5 years of experience in pharmaceutical manufacturing or a GMP-regulated environment.
· Strong knowledge of GMP regulations and guidelines.
· Experience with process validation, equipment qualification, and regulatory compliance.
· Proficiency in data analysis
· Excellent problem-solving and troubleshooting skills.
· Strong written and verbal communication skills.
· Self-motivated and customer centric.
· Experience with Microsoft applications (Outlook, Excel, Word)
Core Competencies
· Technical Expertise: Strong understanding of pharmaceutical manufacturing processes, equipment, and regulatory requirements.
· Analytical Skills: Ability to analyze complex data and identify trends to drive process improvements.
· Attention to Detail: Meticulous approach to documentation and adherence to regulatory standards.
· Collaboration: Effective teamwork and communication skills to work with cross-functional teams.
· Adaptability: Ability to manage multiple tasks and adapt to changing priorities in a fast-paced environment.
· Problem-Solving: Proactive approach to identifying and resolving process-related issues.
· Leadership: Capability to train and mentor manufacturing personnel on process operations and GMP compliance
Wat bieden wij?
What’s On Offer:
Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.
We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.