Application and Validation Scientist

Merck•Burlington, MA

2d•Onsite

About The Position

The Field Validation Scientist position is part of a North American Service team supporting MilliporeSigma's BioMonitoring sales group within the Advanced Solutions Business Unit. Our BioMonitoring group is focused on supporting the microbiology needs of the Food, Beverage, and Pharmaceutical Industries. This position requires 50-70% travel.

Requirements

Bachelor’s Degree in Chemical Engineering, Biomedical Engineering, Chemistry, Biology, or other Engineering or Life Science discipline.
1+ years lab experience in the pharmaceutical industry.

Nice To Haves

Ability to develop and execute IQ/OQ validation protocols.
Extremely proficient planning and organizational ability, able to coordinate work schedule on short notice.
Comprehensive knowledge of cGMP regulations and documentation requirements.
Strong analytical and problem-solving skills; effective writing and verbal communication skills; ability to be a team player/work well alone and with others, ability to multi-task.
Customer-focused, agile, flexible and adaptable, proactive/action oriented, well developed customer-facing skills.
May lead small projects with limited risks and resource requirements.

Responsibilities

Execute IQ/OQ validation protocols for microbiological testing equipment at customer sites used in the testing of pharmaceutical products or processes: install and prepare equipment and supplies, perform testing, document test results, write reports and maintain records.
Ensure all systems are running according to necessary specifications and operate within regulations to ensure testing of quality products.
Train customers on equipment operation.
Provide PQ consulting to assist customers with test method suitability execution.
Troubleshoot equipment on-site if needed.
Cross functionally assist in calibration/preventive maintenance services.
Coordinate with customers and various internal functions to complete validations (customer, technical service, sales, and marketing).
Partner with the sales team to support the sales process, development of opportunities.
Prepares weekly and monthly reports, plans and manages workload and budget.
Assist in development of testing protocols.