Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,400 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing. Your Work Matters. At Cambrex, we strive to build a culture where all colleagues have the opportunity to: + engage in work that matters to our customers and the patients they serve + learn new skills and enjoy new experiences in an engaging and safe environment + strengthen connections with coworkers and the community We’re committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes medical, dental, vision, Life, LTD, retirement savings and more! Your Future Matters. Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today! Job Overview The Process Engineer 2 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 + Composing batch production records, cleaning records, SOPs, campaign reports, supplements, and investigation/deviation reports as needed 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 + Working with Process Improvement resources where applicable to drive optimization of production + Providing targeted training and process support to production areas, including training on new processes, as well as on-site oversight of key processing steps + Working in a team environment that includes cross-departmental participation from Facilities, Chemical Research and Development, Regulatory, Quality Control, and Analytical Research and Development + Developing plans and process fits for production + Developing and maintaining IQ, OQ and PQ documents and protocols + Leading and coordinating troubleshooting efforts where appropriate, investigating process problems and deviations, and preparing appropriate reports on findings + Participating in HAZOPs and other S&IH reviews, and providing guidance on corrective actions when needed + Where required, providing PFDs, energy balances, material balances, environmental calculations, and other pertinent production information + Working with appropriate departments to set up codes, label requests, and MSDS revisions + Completing CAPAs and audit action items as assigned Qualifications/Skills + Ability to integrate information from diverse areas/sources and independently develop creative solutions + Excellent verbal and written communication and interpersonal skills, problem-solving, and organizational skills + Demonstrated ability to work in a diverse team environment + Proficiency with Microsoft software (Word, Excel, PowerPoint) + Exposure to broader analytical techniques (i.e., beyond USP compendial testing). Some supervisory experience + Experience / proficiency with various information and documentation software (SAP, TrackWise, etc.) + Leads with Integrity and Respect; Delivers Results; Demonstrates Business Acumen; Fosters Collaboration and Teamwork; Champions Change; Engages an d In spires; Coaches and Develops Education, Experience & Licensing Requirements + BS in Chemical Engineering, plus 3 - 7 years of experience in a 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 #LI-RD1 + Some active work, exerting up to 50 pounds of force occasionally, and/or the amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. The daily work is performed is primarily in a production setting. Walking and standing are required regularly. + Use of ladders and roof access may be required. + Position also requires visual acuity, talking and fingering. + Involves regular use of basic PPE (personal protective equipment) such as supplied air respirator, negative pressure respirator, gloves, safety glasses, shielding clothing. + A Chemical Manufacturing environment. Basic hazards associated with a small chemical plant environment such as: flammables and/or toxic materials, heavy item movement, large machinery operation.