Cindy Gilbert Email & Phone Number

Greater Boston

Cambridge, Massachusetts, United States

Brentwood, Nh

Portsmouth, New Hampshire

Responsible for the investigation of process deviations aimed at identification of root cause, and implementation of corrective actions to prevent recurrence. Required to work in a cGMP environment, have a high working knowledge of mammalian manufacturing processes, the ability to manage multiple ongoing projects concurrently as well as mentor and train others within the group, have strong meeting facilitation and conflict resolution skills, a strong technical writing capability, be action oriented, and be compliant minded while performing investigations.

Support ongoing operations through technical assistance as it relates to the manufacturing and process automation systems. Provide a technical resource to operations customers to ensure that equipment and facilities are designed and operating to meet production needs.Responsibilities include:• Develop technical knowledge on manufacturing equipment and process automation systems• Manage resolution of equipment breakdowns and quality issues in the suites• Provide SME support to Manufacturing and other departments for the design and operation of process automation equipment• Conduct troubleshooting and technical analyses on manufacturing equipment and process automation systems including PI data analyses, CIP/SIP circuit review, flow path analyses, code review/troubleshooting, etc.• Assist with technical transfer of new processes into the facility• Complete change request lot assessments to support lot release• Participate in internal and customer meetings as Controls SME• Participate in audits and inspections as Controls SME• Planning and execution of plant projects involving complex automation changes and significant process improvements including lump sum capital projects• Execute test scripts (design, execution, simulation, wet testing) • Own change requests and complete change request tasks to support project completion• Perform change request assessments• Assist the Quality department with deviation investigations• Perform Controls review/approval of deviations• Participate in RCAs as Controls representative• Own and execute completion of CAPA actions• Participate in quality risk assessments• Review/revise Controls and Manufacturing related SOP’s, Functional Specifications, and work instructions as a result of CAPA, equipment/process changes, error prevention activities, etc.

Responsibilities included reviewing, editing, and dispositioning deviation reports. Perform product changeover procedures for manufacturing. Review of logbooks and charts for all monitoring equipment used in cGMP processes. Review of other GMP documentation including test methods, SOPs, sanitization forms.

Responsible for the execution of test methods aimed at ensuring interoperability between gigabit Ethernet networking equipment both cross manufacturers as well as legacy equipment communicating with new technology. Responsible for testing the equipment compliance with IEEE standards.