ROLE SUMMARYMS&T Process Engineer role within the Site Technical Services group at the Rocky Mount NC manufacturing site. This individual will apply advanced manufacturing, science, and technology to support the manufacture of small and / or large volume parenteral products, or process improvement.ROLE RESPONSIBILITIES
forming trending and monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process drift.
Implementing potential process improvements in conjunction with manufacturing operations.
Participating in start-up of new facility, equipment, or processes in manufacturing.
Assisting in documenting changes/updates to manufacturing processes and working with manufacturing, engineering and validation to implement those changes.
Providing technical/scientific support on project deliverables, e.g. technology transfers, remediation initiatives, plan reports, etc.
Utilizing small-scale production processes and using scaled-down lab processes to enable process troubleshooting.
Individual responsible for executing projects/tasks assigned by Manager.
Execution of laboratory studies and writes technical reports summarizing laboratory results to support product impact assessments required for investigations into process discrepancies or out of specification test results
Assures professional and quality performance in all activities, meeting times, cost and cGMP requirements.
Proposes process improvement opportunities and / or corrective actions to increase yield, maximize production capacity, reduce product costs and decrease process variability while maintaining regulatory compliance
Adaptive and flexible to scheduling of engineering runs
Bachelor's degree in Engineering or Science with a minimum of 1 year of experience working in a pharmaceutical manufacturing site is required.
Excellent communication skills and attention to detail are required.
Degrees in Chemical Engineering, Materials Science, Biomedical Engineering, and Biomanufacturing sciences preferred.
Familiarization with global regulations on drugs, medical devices, combination products or validation / qualification requirements preferred.
Experience with aseptically filled or terminally sterilized small volume and / or large volume parenteral products preferred.
2+ years of experience in a pharmaceutical manufacturing site preferred.
OTHER JOB DETAILS
Last Date to Apply for Job: 5/15/2020
Eligible for Relocation Package
Eligible for Employee Referral Bonus
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