Eric Merrell Email & Phone Number

Hilleroed, DK

Hilleroed, DK

Supplying Validation Services in the biotech and pharma sectors, specializing in steam sterilization and temperature mapping of SIPs, autoclaves, ovens, warehouses and CTU's. Fluent in cGMPs, 21 CFR Part 11, GAMP5 and authoring of protocols and summary reports.Major project to date: Served as Contract Technical Lead on SIP project at AGC Biologics in.

Burlington, MA, US

Supporting global MilliporeSigma Life Sciences sites with Validation guidance mainly in ISO 9001 complaince. Providing Equipment and Process Validation (primarily sterilization) guidance to team developing Life Science Validation Strategy document. Develop and maintain MS Teams Sector and Cluster level Community of Practice Project site in order to.

Paris, France, FR

Author and execute validation protocols (IQ/OQ/PQ) in accordance with Site MVP. Perform periodic review of systems and equipment, assess risk from validation perspective for change control quality system.

Commissioning and Qualification of utilities and plant systems to support long term major expansion project for client as well as shutdown activities.

New York, New York, US

Author and execute Validation protocols (IQ, OQ, PQ, RQ) for on-site sterilization and depyrogentation equipment. Quality Observer (QO) for media fill program. Perform Periodic Review of systems and equipment. Author Quality Risk Assessments (QRA).

Waltham, Massachusetts, US

Write and execute commissioning and validation documents on equipment, instruments, facilities, utilities, processes and computer systems, utilizing the lifecycle approach, in accordance with the Site Validation Master Plan, project specific Validation Plans, and departmental SOP’s.

Dublin, Ireland, IE

Researching, designing and executing test procedures (relative to FDA cGMP, NRC, EU, Canadian Health and OSHA standards) to provide a high degree of assurance that processes and equipment meet pre-determined specifications and quality attributes.

Fridley, Minnesota, US

Formulation of lyophilized parenteral solutions used in conjunction with Dry Top Elution generators for use in radiopharmaceutical imaging projects. Experienced in use and troubleshooting of aseptic filling operations, autoclaves, depyrogenation ovens, and lyophilizers. Experience in SOP's, batch records, CAPA, cGMP, 21 CFR Part 11.

London, England, GB

Responsible for developing new business in specified territory and collecting of premiums on a monthly basis.

Washington, DC, US

Served aboard the nuclear submarine USS Ulysses S. Grant (SSBN-631) making 3 nuclear deterrent patrols. Served as gage calibration officer and damage control team leader for the auxiliary machinery room.