Validation Project Manager - IIMadison, New Jersey
Category:Scientific & Clinical
Title:Validation Project Manager - II
Schedule:8am to 5pm Mon - Fri.
Provide project management and/or technical oversight, planning, coordination and support to drug-product manufacturing sites for projects related to:
+ + API-related changes, including supplier and API-process changes
+ Process Robustness and Product maintenance (e.g. due to regulatory changes)
+ life cycle management, technical trouble shooting
+ Process and method validation/qualification
+ Overarching changes to products or materials.
+ Investigation support, mitigation management of Complaints, deviations and OOS
+ CMO product transfers, including CMO-CMO, site-CMO and R&D-CMO
Identification, initiation, support and follow up of projects for continuous improvement of manufacturing processes (process robustness initiative) with target to improve efficacy (e.g. reducing off specs and cycle times, Right First time projects) at the manufacturing sites. Projects include:
+ + Change control for drug-products (APIs, excipients, packaging),
+ Contract manufacturing site technical assessments
+ Qualification/validation approaches.
+ Technology Transfers
Support of direct knowledge transfers involving CMOs, support of development of global key technology platforms, technical expertise and MMD technology network.
Facilitation of communication and interface for manufacturing sites to other global/local departments such as Quality, Supply Chain Management, Regulatory Affairs, Pharma R&D, Global Supplier Management, and CMO Organization.
Support or lead investigation teams established to solve major quality issues occurring with our AH pharma products.
+ Undergraduate degree in Sciences (Engineering, Manufacturing Technology, Pharmaceutical Technology, or Industrial Chemistry preferred).
+ At least 3 years of experience in technology or manufacturing position in a Pharmaceutical, Food manufacturing or Fine chemicals producing company or in extended experience in an academic environment of Pharmaceutical/Chemistry departments.
+ At least 3 year Experience in a regulated environment in interdisciplinary project management, one year of which is in Pharmaceutical technology, Industrial Chemistry, or Food technology).
+ Regulatory background incl. FDA and EMEA requirements or motivated to acquire this quickly.
+ Strong knowledge of GMP requirements or motivated to acquire this quickly.
+ Experienced in internal business processes and organization.
+ Travel requirement: willing to travel to the different production locations (up to 25 % of the time)
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.