Senior Process Engineer, Technical Operations - Molecule Drug Substance

Senior Process Engineer, Technical Operations – Drug Substance

We are a research‑intensive biopharmaceutical company dedicated to delivering innovative health solutions. This role is part of an agile small‑molecule manufacturing site that focuses on quality, safety, and operational excellence.

• Technical & Process Leadership:
  Provide technical leadership for API manufacturing processes including chemical synthesis, purification, crystallization and drying. Serve as process owner for assigned unit operations, lead design reviews, commissioning, qualification and startup, drive scale‑up, technology transfer and validation activities, analyze process data, and provide troubleshooting support during manufacturing campaigns.
• Technology Transfer & Commercialization:
  Lead execution of technology transfers for new products and processes, partner with global R&D and network sites to ensure robust process knowledge transfer, drive process fit assessments, develop and optimise batch documentation and process instructions, and support integration of new technologies into manufacturing operations.
• Process Optimization & Operational Excellence:
  Partner with Manufacturing to ensure safe, efficient and reliable plant performance, identify and implement improvements in process robustness, product quality, yield and throughput, lead continuous improvement initiatives, use root‑cause analysis to resolve deviations and recurring issues, monitor process performance and trends, and contribute to debottlenecking, cleaning, and turnaround optimisation.
• Compliance & Documentation:
  Ensure all activities comply with cGMP, safety and environmental standards, lead campaign preparation, execution and post‑campaign review, own or approve batch record updates and documentation improvements, support regulatory inspections and audits, and maintain high standards of data integrity and technical documentation quality.
• Cross‑Functional Collaboration & Influence:
  Act as a technical representative within cross‑functional teams, provide clear technical direction, lead or contribute to cross‑functional initiatives, influence decision‑making, and support knowledge sharing and best‑practice transfer across the network.

• Degree in Chemical Engineering, Chemistry or a related discipline.
• 5+ years of experience in API manufacturing, process development or pharmaceutical operations (PhD may offset experience).
• Strong experience in API processing operations, scale‑up to commercial manufacturing, technology transfer, validation and process support.
• Good understanding of cGMP manufacturing and regulatory expectations.
• Experience in troubleshooting and process optimization in a manufacturing environment.

• Strong analytical capability and ability to interpret complex data to drive decisions.
• Demonstrated ability to lead technical work streams or projects.
• Excellent problem‑solving skills with a structured, science‑based approach.
• Effective communicator who can influence cross‑functional stakeholders.
• Proven ability to manage multiple priorities and deliver results in a dynamic environment.
• Proactive, self‑driven mindset focused on continuous improvement and ownership.

• Salary range: $ – $ per year, plus annual bonus and long‑term incentive, if applicable.
• Medical, dental and vision insurance for employee and family.
• 401(k) retirement plan.
• Paid holidays, vacation and compassionate and sick days.
• Comprehensive benefits package as described at

Merck & Co., Inc. is an Equal Employment Opportunity Employer and provides equal opportunities to all employees and applicants for employment. The company prohibits discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status, or any other legally protected characteristic. For more information about rights under U.S. Equal Opportunity laws, visit the EEOC websites.