Engineering & Facilities
Responsible engineer supporting Cambridge commercial and clinical manufacturing. Maintain validated state of equipment by following the defined change control system, specifying required validation activities, and overseeing annual revalidation efforts. Lead Operability Reviews during tech transfer of new products into facility and define the necessary modifications and improvements for the campaign. Specify, procure, and define validation requirements for new equipment, modifications, and projects. Verify that all equipment and processes are properly configured prior to manufacturing. Respond to process and equipment related issues during manufacturing campaigns. Lead multi-disciplined problem solving task teams. Create and maintain relationships with other sites to develop and promote best practices. Specify and implement modifications to improve operational performance and compliance. Manage small capital projects up to $1MM. Convey necessary information to documentation for the preparation of SOP’s and other controlled documents. Uphold, define, and police safety procedures and safe practices.
Direct experience supporting manufacturing in a regulated industry. Significant experience creating and executing GMP validations. Trained in formal problem solving techniques. Expertise in equipment design, installation, and start-up. Demonstrated ability to work in and lead cross-functional teams. Good computer skills including database, programming, and CAD. Knowledge of control systems and HMI’s based on PLC and DCS technologies. Experience with any/all of the following unit operations or technologies: mammalian cell culture, mixing, CIP, COP, SIP, preventative maintenance, filtration, cross-flow filtration, protein purification, sterilization, and chromatography.
BS w/7 or MS w/5 years experience.