The Process Engineer II 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
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
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 with minimal oversight
Leading efforts to troubleshoot and investigate process problems and deviations with minimal guidance, 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
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.
BS in Chemical Engineering, plus 3 – 7 years or more of experience in manufacturing environment, preferably in pharmaceutical manufacture; or equivalent education/experience
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
Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
Cambrex Charles City offers an extraordinary opportunity, a competitive salary, and an exceptional benefits package including medical, dental, vision care and prescription, life, LTD, STD; 401(k) with employer match; tuition reimbursement; and the ‘Arthur I. Mendolia Scholarship Program.’ Relocation assistance will be offered for this position.
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