Senior Project Engineer Process Automation

NCBiotech; Hillsborough (NC); On-site; USD 100,000 - 185,000; Full time

Benefits offered by this job

Annual bonus

Job summary

Genentech in Oceanside is seeking a Senior Project Engineer for Process Automation Systems to own the full project lifecycle. You will design, implement and validate automation across manufacturing, packaging, and warehouse operations, aligning with GMP, FDA and EMA standards.

Strong background in automation architecture and project leadership is required; travel 50% or more is expected for global project work, with on-site presence during FAT/SAT activities.

Qualifications

• Bachelor’s degree in Automation Engineering or related field.
• 5+ years of experience in pharmaceutical/biotech automation and validation.
• Experience with regulatory standards (FDA/EMA) and GMP requirements.

Responsibilities

• Lead planning, design, specification, procurement, implementation, and qualification of process automation systems (DCS, PLC/SCADA, MES, data historian).
• Define global automation architectures and system concepts.
• Manage automation integration with process equipment, utilities, robotics, packaging & inspection, and warehouse automation.
• Act as technical and commercial interface to suppliers, integrators, and procurement teams.
• Collaborate with cross-functional teams to align scope with priorities and stakeholders, provide progress updates and risk mitigation.
• Lead CSV, qualification activities, and commissioning in GMP/FDA/EMA contexts.

Skills

Automation architecture design

Project execution

Commissioning & validation

Regulatory compliance

CSV, GMP, FDA/EMA

Education

Bachelor in Automation Engineering

Bachelor in Mechatronics

Tools

DCS

PLC/SCADA

MES

Data historian

Job description

The Position

This role is an integral part of our Automation and Digital Engineering team, which is 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.

The Opportunity

As a Senior Project Engineer for Process Automation Systems, you will be a Subject Matter Expert (SME) responsible for delivering advanced automation solutions for manufacturing, packaging, and warehouse operations. You will take ownership of the entire project lifecycle, ensuring compliance, performance, and successful execution while driving progress in digital manufacturing and Industry 4.0 initiatives. Key duties and responsibilities include:

• Leading the planning, design, specification, procurement, implementation, and qualification of process automation systems, including DCS, PLC/SCADA, MES, and data historian platforms.

• Defining global automation architectures and system concepts, including feasibility studies and alignment with Roche engineering standards.

• Managing automation system integration with process equipment, utility systems, robotics, packaging & inspection systems, and warehouse automation.

• Acting as the technical and commercial interface to suppliers, integrators, engineering firms, and procurement teams, driving supplier innovation and performance.

• Collaborating with multidisciplinary teams to align automation scope with project priorities and stakeholder expectations, providing regular progress updates and risk mitigation strategies.

• Leading Computer System Validation (CSV), qualification activities, and commissioning efforts in compliance with GMP, FDA, EMA, and cybersecurity standards.

• Supporting digital transformation initiatives through advanced process control, batch analytics, smart manufacturing, and IT/OT convergence solutions.

Who You Are

• 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) assignment required to meet the business need (i.e. weekly commuting and/or temporary remote assignment, including on-site presence during FAT/SAT activities, international project assignment of 1 to 3 years)

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. This position also qualifies for the benefits detailed in this link.

This is an on-site position; no remote options are available at this time.
Relocation benefits are not approved for this posting.

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Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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