Sr Process Engineer

About the role

Serve as the Engineering subject matter expert for a specific process area (cell culture, harvest, purification, clean-in-place, or utilities systems).

Ensure systems remain in a qualified state.

Act as technical owner for system lifecycle including design, installation, qualification, production support, deviation resolution, maintenance, and decommissioning.

Monitor system reliability and performance.

Develop and implement engineering solutions to complex problems.

Lead programs related to system qualification, asset management, project execution, and Good Engineering Practices.

Support development of site staff on technical and procedural topics.

Responsibilities

• Develop engineering deliverables including Process Flow Diagrams, P&IDs, System Specifications, and Functional Specifications.
• Implement system modifications under cGMP change control.
• Develop and execute FAT, commissioning protocols, and qualification protocols.
• Develop calibration and preventative maintenance plans.
• Lead deviation investigations and implement corrective and preventative actions.
• Participate in capital planning, spending, and tracking.
• Lead small to medium projects under $5M.
• Interface with cross-functional teams to meet project goals.
• Stay current with industry best practices and technologies.
• Select and apply appropriate technologies, designing equipment, and diagnosing process issues.
• Make data-driven decisions using engineering principles.
• Ensure impact to product quality, safety, reliability, and throughput.
• Maintain regulatory compliance and validation requirements.
• Troubleshoot factory floor issues and support capacity planning.
• Manage impact to uptime, batch continuity, and manufacturing schedule.
• Respond to urgency and severity of equipment failures.
• Determine escalation thresholds.
• Balance short-term mitigation versus long-term solutions.

Qualifications

• Bachelor’s degree in Engineering.
• 3 or more years of relevant experience.
• Engineer-in-Training (EIT) or Professional Engineer license preferred.
• Demonstrated track record supporting process operations and projects in an FDA-regulated environment.
• Knowledge of engineering principles including fluid mechanics, heat transfer, thermodynamics, and mass transfer.
• Experience applying project management methodologies.
• Understanding of commissioning and qualification protocol development.
• Direct experience with systems such as bioreactors, centrifugation, chromatography, tangential flow filtration, CIP, autoclaves, clean utilities, and HVAC.
• Familiarity with instrumentation and sensing technologies in pharmaceutical manufacturing.
• Experience with regulatory requirements and GMP environments.
• Experience supporting large capital projects.
• Familiarity with batch control systems, data historians, SQL, and scripting (preferred).
• Knowledge of automation, PLCs, power systems, and controls (desirable).
• Proficient in MS Office (Word, Excel, PowerPoint) and MS Project.
• Ability to work in fast-paced, cross-functional teams.
• Strong planning, prioritization, and escalation judgment.

Pay

$89,900.00 - $141,240.00 U.S. Base Salary Range.

Schedule

Occasional ladder climbing.

Ability to lift up to 25 lbs.

Participation in 24/7 on-call rotation.

Infrequent travel up to approximately 25% during project activities.