Senior Project Engineer Process Automation
About the role
This role is an integral part of our Automation and Digital Engineering team, dedicated to delivering cutting-edge process automation solutions that bridge advanced manufacturing processes with innovative digital technologies. As a member of this team, you will play a key role in designing, implementing, and managing automation systems across pharmaceutical and biotech manufacturing, packaging, and warehouse operations. You will collaborate closely with multidisciplinary stakeholders and global teams to ensure compliance, performance, and alignment with our digital transformation initiatives. This is a unique opportunity to contribute to groundbreaking projects shaping the future of pharmaceutical production.
Responsibilities
- Lead the planning, design, specification, procurement, implementation, and qualification of process automation systems, including DCS, PLC/SCADA, MES, and data historian platforms.
- Define global automation architectures and system concepts, including feasibility studies and alignment with Roche engineering standards.
- Manage automation system integration with process equipment, utility systems, robotics, packaging & inspection systems, and warehouse automation.
- Act as the technical and commercial interface to suppliers, integrators, engineering firms, and procurement teams, driving supplier innovation and performance.
- Collaborate with multidisciplinary teams to align automation scope with project priorities and stakeholder expectations, providing regular progress updates and risk mitigation strategies.
- Lead Computer System Validation (CSV), qualification activities, and commissioning efforts in compliance with GMP, FDA, EMA, and cybersecurity standards.
- Support digital transformation initiatives through advanced process control, batch analytics, smart manufacturing, and IT/OT convergence solutions.
Requirements
- Bachelor’s degree in Automation Engineering, Mechatronics, or a related discipline, with 5+ years of experience, preferably in the pharmaceutical or biotech industry; Master’s degree is a plus.
- Strong background in automation architecture design, project execution, commissioning, and validation.
- Demonstrated ability to execute complex scope on mid-sized to large-scale projects.
- Experience with regulatory compliance (FDA, EMA) and GMP requirements for synthetic molecule manufacturing operations.
- Project delivery experience in pharmaceutical manufacturing environments.
- Significant travel (50% or more) required, including weekly commuting, temporary remote assignments, on-site presence during FAT/SAT activities, and international project assignments of 1 to 3 years.
Pay
The expected salary range for this position based on the primary location of Oceanside is $99,820 - $185,380. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.
Benefits
This position qualifies for the benefits detailed in this link.
Schedule
This is an on-site position; no remote options are available at this time. Relocation benefits are not approved for this posting.