Overview:
The Process Engineer I will be responsible for implementation of projects for the manufacture of APIs and bulk intermediates and other products from development through piloting and/or commercial production.

Responsibilities:

• Writing batch records, cleaning records, SOPs, campaign reports, supplements, and investigation/deviation reports as needed to support production operations
• Monitoring KPIs and using process data to identify and execute improvements to new and existing products to achieve improved yields, quality or customer expectations
• Working with process improvement to identify and execute Kaizen events
• Providing training and process support to production areas including training on new processes and on-site oversight of key processing steps
• Working in a team environment that includes cross-departmental participation from Engineering, Research and Development, Regulatory, Quality Control, Analytical Development and Operations
• Developing plans for production of pilot and commercial volumes of product
• Developing and maintaining IQ, OQ and PQ documents and protocols
• Troubleshooting, investigating process problems and deviations, and preparing appropriate reports on findings
• Participating in HAZOPs and providing guidance on corrective actions when needed
• Providing PFD and P&ID generation, energy balances, material balances, environmental calculations and other calculations and formulations as needed
• Working with appropriate departments to set up codes, label requests, and MSDS revisions
• Completing CAPAs and audit action items as assigned

Qualifications / Skills::

• Knowledge of and/or direct experience in a cGMP environment is preferred
• General knowledge of chemical operations equipment and manufacturing operations
• Proficient in windows based environment including word processing, spreadsheet and data base programs

Qualifications:

• BS in Chemical Engineering, plus 1 – 3 years of experience in manufacturing environment, preferably in pharmaceutical manufacture; or equivalent education/experience

• Writing batch records, cleaning records, SOPs, campaign reports, supplements, and investigation/deviation reports as needed to support production operations
• Monitoring KPIs and using process data to identify and execute improvements to new and existing products to achieve improved yields, quality or customer expectations
• Working with process improvement to identify and execute Kaizen events
• Providing training and process support to production areas including training on new processes and on-site oversight of key processing steps
• Working in a team environment that includes cross-departmental participation from Engineering, Research and Development, Regulatory, Quality Control, Analytical Development and Operations
• Developing plans for production of pilot and commercial volumes of product
• Developing and maintaining IQ, OQ and PQ documents and protocols
• Troubleshooting, investigating process problems and deviations, and preparing appropriate reports on findings
• Participating in HAZOPs and providing guidance on corrective actions when needed
• Providing PFD and P&ID generation, energy balances, material balances, environmental calculations and other calculations and formulations as needed
• Working with appropriate departments to set up codes, label requests, and MSDS revisions
• Completing CAPAs and audit action items as assigne