Process Engineer

A brief overview The Process Engineer is responsible for supporting, maintaining, and optimizing large‑scale upstream and downstream production equipment and instrumentation to ensure reliable, continuous manufacturing operations with minimal downtime. Leveraging strong process mapping and analytical skills, this role leads the development and execution of process improvement initiatives, conducts engineering design evaluations, and identifies opportunities to enhance efficiency and product quality across USP/DSP processes. In addition, the Process Engineer evaluates equipment needs, researches potential solutions, and provides informed recommendations to management. The role also partners closely with third‑party contractors to ensure timely completion of IQ/OQ/PQ activities. Strong independent troubleshooting capabilities are essential. What you will do Maintain all USP/DSP equipment and instruments at the ready-to-run status to ensure that manufacturing is continuously in operation with minimal downtimeWhen needed, be responsible for design, installation, and qualification of batch processing tanks, solvent recovery system, filter dryers, filtration system, ultra-low freezers, HVAC, solvent distribution and recovery system, compressed air, purified water, and wastewater systemAbility to learn the automation system trouble shooting including a programed recipe fixing, changing and testing.Support production on CAPEX projects for production facility and equipment improvements in order to increase production efficiency and reduce costPerform activities associated with the design and qualification of the new and existing USP/DSP equipment used in a manufacturing plantSupport large-scale production process development and optimization projectsProvide technical guidance and support investigations for process related deviations, change control and operational excellence projectsOversee implementation, commissioning, and qualification of USP/DSP facility and process equipmentMaximize the success rate for production operations by instituting programs to minimize human error, mechanical failure, contaminations, and procedural errorMaintain a safety-first approach in the large-scale manufacturing workplaceCommunicate operational status regularly to senior management and corporate management, as required and appropriate. Communications include written documents and formal / informal oral presentationsMaintain a high level of compliance and efficiency to drive the organization to world-class manufacturing standardsCreate new process and equipment drawings to existing processes based on specifications and standardsUpdate and maintain drawings and P&ID to reflect changes to existing processesResponsible for trouble shooting and providing corrective action directivesTroubleshoot process equipment and ensuring that equipment works to its specifications and appropriate capacitiesCreate, execute validation protocols and write validation summary reportsDraft of new procedures, SOP’s and protocols as well as training of staff for these expectationsWrite technical reports to support the process development data.Write standard operations procedures, standard test procedures, master batch records, and other related GMP documents. Qualifications Bachelor's degree in a life sciences or engineering field Master's degree (preferred)Minimum 5 years of experience of pharmaceutical engineering and/or manufacturingThorough understanding of engineering fundamentalsDeep knowledge of cGMP, pharmaceutical manufacturing facility, large-scale equipment, and engineering principlesGood understanding of computer programming and software developmentAbility to troubleshoot equipment problems and perform complex system tests.Technical knowledge of USP/DSP processes / equipment / automation / utilities (e.g. large-scale chemical reactor, cleavage vessel, deprotection vessel, solvent delivery system, agitator, batches processing, tank, filtration, purified water system, heat exchanger, HVAC, etc.)Equipment Qualification and Validation IQ /OQ / PQ and SOPsExcellent written and oral communication skillsAbility to communicate in a proactive and solutions-focused manner, including keeping management aware of potential issuesAbility to work independently and manage one’s timeAbility to schedule and host internal/external meetings and negotiate with vendors, contractors, and customers for the best interest of the production department. Excellent computer knowledge, including Microsoft Word and ExcelCommunicate effectively and ability to function well in a team environmentAbility to effectively organize, multitask, and work in a fast-paced, deadline driven work environmentDetail oriented with the ability to troubleshoot and resolve equipment and process problems and deviationsStrong analytical and problem-solving skills.Proficient in reading schematics and diagrams as well as other written materialsHigh level of safety awareness.Good background for Automation systems software, i.e. DeltaV and FactoryTalk, is preferred.Creative thinking skills with detail orientation.Excellent manual dexterity. Base Annual Salary Range: $83,089 - $114,247 Placement of new hires in this wage range is based on several factors including education, skill sets, experience, and training. Total Rewards We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days. Corporate Social Responsibility Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness. EcoVadis has awarded Bachem Gold Medal status in their assessment of Bachem. Bachem Americas is an Equal Opportunity Employer As an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status.