Cambrex is the small molecule company that provides drug substance, drug product and analytical services across the entire drug lifecycle. Known for our scientific and manufacturing excellence and customer focus, we offer a range of career opportunities across our global network of locations. As a team, we share one goal – to improve the quality of life for our customers’ patients across the world.
The Senior Process Engineer 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.
- Writing batch records, cleaning records, SOPs, campaign reports, supplements, and investigation/deviation reports with minimal oversight to support production operations
- Developing and maintaining IQ, OQ and PQ documents and protocols with minimal oversight
- Providing mentorship and peer review for junior engineers during completion of documents and investigations
- Identifying and monitoring KPIs and using process data to identify and execute improvements to new and existing products to achieve improved yields, quality or customer expectations
- Identifying and executing Kaizen events with support from Process Improvement
- Leading process improvement teams to further identify and execute larger scale process improvements on key products
- 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
- Leading efforts to troubleshoot and investigate process problems and deviations, and mentoring junior engineers on troubleshooting techniques; preparing appropriate reports on findings
- Participating in HAZOPs and providing guidance on corrective actions when needed; leading HAZOPs when required
- 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
- Leading project teams and filling the role of project manager or key customer contact when required
- Developing cost estimates and reviewing with accounting
All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental mission, not specifically detailed in this section may be assigned.
- 7 years or more of experience in manufacturing environment, preferably in pharmaceutical manufacture; or equivalent education/experience; advanced degree in Chemistry or Chemical Engineering preferred
- BS in Chemical Engineering
- 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