Senior Process Engineer, Technical Operations – Small Molecule Drug Product (Oral Solid Dose)

Job description

Job Description We have an exciting opportunity for a Senior Process Engineer, Technical Operations – Small Molecule Drug Product (Oral Solid Dose) to join our growing team. At our company, we aspire to be the premier research-intensive biopharmaceutical company, using the power of leading-edge science to save and improve lives around the world. We are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. Join a purpose-built, agile small molecule manufacturing site where your work will help bring important medicines to patients in the U.S. This facility is designed to move quickly and reliably, receiving technology transfers from commercialization sites and fast-following into production with a focus on quality, safety, and operational excellence. At our site, you’ll be part of a team committed to creating a safe, environmentally responsible, and compliant workplace where people can do their best work. We are building deep small molecule expertise in the U.S., and we want team members who are excited to grow their skills, help improve how we operate, and contribute to a site positioned for future growth. The successful candidate will provide technical leadership and process ownership supporting facility design, commissioning, qualification, and startup through to technology transfer, validation, and ongoing commercial manufacture of oral solid dosage forms. In this role, you will work as a key member of a cross-functional team, initially supporting the capital project and transitioning into process lead responsibilities across technology transfer and commercial manufacturing, driving technical excellence and operational performance. Key Responsibilities Technical & Process LeadershipProvide technical leadership for oral solid dose manufacturing processes, including: Blending and granulation (where applicable) Roller compaction (dry granulation) Tablet compression Film coating and finishing operations Act as process owner / SME for assigned unit operations, equipment, or product processes Provide technical input to the Capital Project Team, supporting: Equipment selection and design reviews Commissioning and qualification (CQV) Startup readiness for OSD manufacturing lines Lead or coordinate process scale-up, technology transfer, and validation activities (e.g. process performance qualification – PPQ) Analyze and interpret process and product data (e.g. blend uniformity, tablet properties, coating performance) to drive data-driven decision-making and performance improvements Provide advanced troubleshooting support for compression, compaction, and coating issues (e.g. weight variability, hardness, sticking/picking, coating defects) Technology Transfer & CommercializationLead or play a key role in execution of technology transfers for oral solid dose products into the facility Partner with global R&D and network sites to ensure robust transfer of formulation and process knowledge Drive: Process fit assessments Scale-up strategy from development to commercial scale Equipment capability and process comparability assessments Own or guide development and optimization of: Master batch records (MBRs) Process descriptions and control strategies Support integration and industrialization of new formulations and technologies (e.g. continuous manufacturing, advanced granulation approaches where applicable) Process Optimization & Operational ExcellencePartner with Manufacturing to ensure safe, efficient, and reliable OSD plant performance Identify, prioritize, and implement improvements in: Content uniformity and tablet quality Process robustness (e.g. compaction consistency, compression stability) Yield, throughput, and cycle time Lead or drive continuous improvement initiatives aligned with operational excellence Use structured problem-solving approaches (e.g. RCA, DOE where applicable) to resolve: Compression issues (e.g. capping, lamination) Compaction variability Coating defects (e.g. color variation, twinning, roughness) Monitor process trends and product quality attributes to proactively identify risks and opportunities Contribute to line optimization, changeover reduction, and debottlenecking activities Compliance & DocumentationEnsure all activities are conducted in compliance with cGMP, safety, and environmental standards Provide technical leadership in campaign preparation, execution, and post-campaign review Own and approve batch record updates, process specifications and control strategies Support regulatory inspections and audits, providing technical input and ensuring inspection readiness Ensure high standards of data integrity and technical documentation Cross-functional Collaboration & InfluenceAct as a technical representative across Manufacturing, Quality, Engineering, Supply Chain, and R&D Provide clear technical direction and influence decision-making across product introductions and commercial operations Lead or contribute to cross-functional initiatives, ensuring alignment to timelines and site objectives Support knowledge sharing and best practice transfer across internal and external networks Qualifications To excel in this role, you will have: Degree in Chemical Engineering, Pharmaceutics, Pharmaceutical Sciences, or related discipline Typically 5+ years’ experience in oral solid dose manufacturing, formulation, or process development (PhD may offset experience) Strong experience in OSD manufacturing operations, particularly: Roller compaction (dry granulation) Tablet compression Film coating processes Experience in process scale-up and commercialization of solid oral dosage forms Demonstrated involvement in: Technology transfer Process validation (PPQ) Manufacturing support Good understanding of cGMP manufacturing and regulatory expectations Experience troubleshooting tableting and coating processes in a commercial environment Key Skills: Strong analytical capability with ability to interpret process and product performance data Demonstrated ability to lead technical workstreams or projects Excellent problem-solving skills with structured, science-based approach Effective communicator with ability to influence cross-functional stakeholders Proven ability to manage multiple priorities in a dynamic manufacturing environment Proactive, self-driven mindset with strong focus on continuous improvement and ownership Our Culture We keep the patient at the heart of everything we do and strive to deliver solutions for some of the world’s most challenging healthcare needs. We believe innovation happens when empowered individuals collaborate in an inclusive, high-performing environment. So, if you are ready to: Play a key role in delivering oral solid dose manufacturing capability Take ownership of formulation and process performance at commercial scale Develop as a technical leader in a high-impact manufacturing environment …we encourage you to apply. #ELKVACOE Required Skills: Adaptability, Biopharmaceutical Industry, Change Control Processes, Chemical Engineering, Customer-Oriented, Deviation Management, Engineering Standards, Equipment Selection, Good Manufacturing Practices (GMP), Maintenance Engineering, Manufacturing Process Validation, Operational Excellence, Oral Solid Dosage, Pharmaceutical Sciences, Process Optimization, Regulatory Compliance, Root Cause Analysis (RCA), Strategic Thinking, Teamwork, Technical Leadership, Technical Support, Technical Transfer, Technology Transfer, Vibratory Rollers Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employ