ROLE SUMMARY   As a member of the Gene Therapy Manufacturing Technical Services Team located in Sanford, NC, the Drug Product Engineer is a technical process owner of assigned Drug Product unit operations and serves as a scientific and technical representative for process and equipment related projects.  During the initial phase this role will focus on supporting the Gene Therapy facility start-up, process transfers, clinical material production and process validation. Following execution of process validation the scope of work will include authoring of Biological License Agreement(BLA) leaflets, process performance monitoring, support for change controls and deviations as well as identification of process improvements.   ROLE RESPONSIBILITIES Authors process descriptions, process flow diagrams and risks assessments Designs technical and engineering studies, writes technical reports summarizing study results and generates necessary data to...

Why Patients Need You Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what’s possible and taking action.   Role Summary Provides technical expertise and operational support for Drug Product Operations and specifically the new Modular Aseptic Processing (MAP) facility.   Partners with shop floor colleagues and supervision to ensure smooth and efficient production of a diverse mix of products.  Assists in equipment troubleshooting activities as needed.  Serves as a subject matter expert within the site for highly automated aseptic preparation, formulation, filling, isolator, or lyophilization systems.  Responsible for...

ROLE SUMMARY The incumbent works as part of a team to perform scientific, operational and process engineering tasks as they relate to technology transfer,  scale-up operations, capital projects and routine manufacturing support.    The incumbent should have the cross-functional scientific ability/skills/knowledge to work in any of the clinical production areas including fermentation/recovery, purification and conjugation chemistry.  Although the incumbent may be hired to work primarily in a particular area, they are expected to have the scientific acumen to quickly adapt to cross-functional training as needed to advance pipeline projects.    The incumbent works with minimal direct supervision and is responsible for leading and executing the design, optimization, implementation, troubleshooting, scale-up, tracking and reporting of a variety of manufacturing processes for clinical and launch campaigns of microbial and conjugate antigen...

ROLE SUMMARY The Process Engineer, Tech Transfer role is accountable for operational representation and delivery of the elements associated with facility/equipment or process change. This includes tech transfer of products/ processes to and from the facility, product re-entry, and changes to improve process robustness and facility capability.   ROLE RESPONSIBILITIES Complete site assessment including process flow diagrams, equipment selection, material planning, and operations schedule for clinical and/or commercial products to be manufactured. Act as the operations lead for incoming campaigns to and from the suites.  This work includes interface with the donating or receiving organization and operations staff.  It also includes technical oversight of campaigns.   Manage change to equipment, automation, and procedures in the manufacturing area. Author and/or reviews manufacturing batch records, solution formulation records, and standard...

Process Engineer, Grange Castle, Dublin   Please note, we may not have an active opening at this time. If your skills and experience match this position, our Talent Acquisition team will connect with you as soon as this opportunity becomes available. Please apply if you would like to be added to this pool of candidates for consideration for future vacancies. *Due to high volume of applications we will be contacting successful candidates only.   One Site, Multiple Opportunities! Are you an experienced Process Engineer looking for your next step within a state-of-the-art manufacturing plant? If so, Pfizer Grange Castle has a permanent, full-time opportunity for you! This role focuses on key site activities such as the execution of trouble-shooting activities, leading investigations and the implementation of cost reduction projects.   About the Role Provide process/equipment engineering support to the ongoing requirements....

Process Specialist / Engineer, Pfizer, Ringaskiddy, Cork   Please note, we may not have an active opening at this time. If your skills and experience match this position, our Talent Acquisition team will connect with you as soon as this opportunity becomes available. Please apply if you would like to be added to this pool of candidates for consideration for future vacancies. *Due to high volume of applications we will be contacting successful candidates only.   About Pfizer Ringaskiddy Pfizer Cork Active Pharmaceutical Ingredient (API) is a multi-award-winning site based in Ringaskiddy close to Cork Harbour and within 8 miles of Cork City. The site has over 600 colleagues and is a key manufacturing facility in the Pfizer Global Supply Network specializing in New Product Introduction and bulk manufacturing of a wide range of Pfizer’s patented and non-patented products.  The site plays a critically strategic role within Pfizer and...