MSAT Expert – Environmental Monitoring (EM)
Location: Verviers
Position Overview:
We are looking for a Subject Matter Expert (SME) in MSAT (Manufacturing Science and Technology) with a deep understanding of environmental qualification, manufacturing environments, analytical testing, and product knowledge. In this role, you will take the lead in environmental monitoring (EM) performance qualification (PQ) activities, ensuring that our manufacturing operations meet the highest standards of compliance and performance.
Key Responsibilities:
* Lead and execute environmental monitoring (EM) performance qualification (PQ) activities to ensure environmental controls are met for manufacturing facilities.
* Provide expertise and guidance in environmental qualification, ensuring adherence to regulatory requirements and best practices.
* Oversee analytical testing processes and contribute to the troubleshooting and optimization of manufacturing processes.
* Collaborate with cross-functional teams to maintain and improve the quality and safety of the manufacturing environment.
* Lead investigations into any environmental monitoring deviations, conducting root cause analysis and implementing corrective actions.
* Support continuous improvement initiatives within manufacturing operations, focusing on enhancing efficiency, compliance, and product quality.
Qualifications:
* Proven experience in MSAT, with a specific focus on environmental monitoring and manufacturing environments.
* Expertise in environmental qualification, performance qualification (PQ), and analytical testing.
* Strong knowledge of regulatory requirements, industry standards, and best practices in environmental monitoring.
* Excellent problem-solving skills, with the ability to lead investigations and implement corrective actions.
* Strong communication and interpersonal skills to collaborate effectively with cross-functional teams.
* Bachelor's or Master's degree in Life Sciences, Engineering, or related field (advanced certifications are a plus).
* years of experience in a related role, ideally within a GMP or regulated environment.
About Planet Pharma:
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.