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Category

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Management

Description

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ROLE RESPONSIBILITIES * Performing 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, costs and cGMP requirements. * Participates on technical teams for discrepancy investigation resolution, equipment or process validation activities, training on new process technologies and on significant changes to manufacturing procedures. * 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. BASIC QUALIFICATIONS * BS in Engineering or Science or similar required * Minimum of 3 years of experience in product development, manufacturing science and technology, sterilization or process validation or process engineering within the pharmaceutical industry required. * 2 years of experience working in a pharmaceutical manufacturing site. * Familiarization with global regulations on drugs, medical devices, combination products or validation / qualification requirements. * Excellent communication skills and attention to details. PREFERRED QUALIFICATIONS * Degrees in Chemical Engineering, Materials Science, Biomedical Engineering, and Bio-manufacturing sciences preferred. * Master's degree with minimum 1 year of experience in product development, manufacturing science and technology, sterilization or process validation or process engineering within the pharmaceutical industry or a PhD degree in science or engineering with 0 to 3 years of experience in product development, manufacturing science and technology, sterilization or process validation or process engineering within the pharmaceutical industry. * Experience with aseptically filled or terminally sterilized small volume and / or large volume parenteral products. * 3 or more years of experience in product development, manufacturing science and technology, sterilization or process validation or process engineering within the pharmaceutical industry. * 2 or more years of experience in a pharmaceutical manufacturing site. PHYSICAL/MENTAL REQUIREMENTS

• Able to stand for extended hours for test runs
• Able to climb ladders/steps
• Able to lift items of up to 25 lbs.
• Must be able to effectively communicate with others

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• May require off shift work to support engineering studies or batches in production environment
• May require some travel to alternate manufacturing site(s) for process observation or meetings
• Weekend support may be required as dictated by project schedule, or customer needs

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