Serán BioScience is seeking a Process Engineer to play a critical role in facility start-up, commissioning of process systems, and operational readiness for our new commercial manufacturing operations. This position will ensure that all systems, equipment, and workflows are designed, installed, and commissioned to meet cGMP standards and support efficient, compliant production. Beyond the initial launch phase, this individual will be instrumental in sustaining manufacturing operations by driving long-term operational excellence. This includes leading continuous improvement (CI) projects to ensure that all systems, equipment, and workflows remain efficient, compliant with cGMP standards, and capable of meeting evolving production demands.
Duties and Responsibilities
Facility & Process System Start-Up
Lead design and engineering activities associated with process equipment for new installations and/or continuous improvementsLead engineering activities for facility process systems through design, installation, and commissioning, including CIP, purified water, solvent distribution, and compressed gasesOversee process equipment installation, commissioning, and qualification (URS, FAT, SAT, IQ/OQ/PQ)Coordinate with vendors and contractors to ensure timely and compliant start-up of manufacturing systemsDevelop and execute commissioning plans, risk assessments, and readiness checklistsProcess Design & Optimization
Design and refine commercial-scale manufacturing processes for oral solid dosage forms and enabling technologiesPerform capacity analysis, cycle time studies, and throughput modeling to ensure production efficiencyImplement Lean and Six Sigma methodologies to reduce waste and improve process reliabilityConduct formal risk assessments for existing process system to proactively mitigate quality and safety risksOperational Readiness
Drive readiness activities for commercial launch, including supporting process validation and GMP documentationPartner with Validation, QA, and Manufacturing to ensure compliance with regulatory requirementsSupport tech transfer from development to commercial scaleCollaborate with the Facilities and Maintenance teams to establish preventive and predictive maintenance schedules for process systemsDraft and review standard operating procedures (SOPs) for the operation, cleaning, and troubleshooting of new process systemsContinuous Improvement
Analyze production data to identify bottlenecks and implement corrective actionsDrive cost reduction initiatives and efficiency improvements without compromising qualityParticipate in deviation investigations and CAPA implementationServe as the primary technical process system owner to ensure stable and robust manufacturingProject Management
Contribute to project timelines, resource planning, and budget adherenceFacilitate cross-functional project meetings and provide regular status updates to senior leadershipProvide engineering input during client audits and regulatory inspectionsProactively identify project risks and implement mitigation strategies
Skills, Abilities and Education Requirements
Required
BS/MS in Industrial Engineering, Chemical Engineering, Mechanical Engineering, or related discipline8+ years of experience in pharmaceutical manufacturing, process engineering, or industrial engineeringHands-on experience with facility start-up, commissioning, and equipment qualificationStrong knowledge of cGMP requirements and commercial manufacturing operationsProficiency in process modeling, workflow analysis, and Lean/Six Sigma toolsExcellent communication and documentation skillsPreferred
Experience with oral solid dosage forms and enabling technologies (e.g., spray drying, blending, granulation, tableting, encapsulation, & tablet coating)Familiarity with facility design for regulated environmentsKnowledge of ERP/MES systems and digital manufacturing toolsProject engineering experience in a regulated industryCore Competencies
Analytical problem-solving and data-driven decision-makingAbility to work cross-functionally in a fast-paced environmentStrong organizational skills and attention to detailContinuous improvement mindset
Physical Requirements
Prolonged periods of sitting or standing at a desk and working on a computerProlonged periods of sitting, standing, and moving throughout a manufacturing environmentMust be able to lift fifteen pounds at timesAdheres to consistent and predictable in-person attendance
Compensation correlates to skills and experience presented by selected candidate. Visit
https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.
Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
Benefits Summary:
Serán employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees’ wellbeing, along with access to pet insurance.
