Principal Process Engineer,

About the role

Supports process and automation improvements in a manufacturing site. Works collaboratively with Manufacturing, Operational Excellence, and Quality to drive improved performance on production equipment. Ensures process design and operation consistently meet Engineering/Quality standards.

Responsibilities

• Support daily operations by improving control systems, addressing obsolescence, and increasing equipment reliability.
• Develop and implement improvement strategies aligned with site priorities and long-term business objectives.
• Troubleshoot and optimize automated equipment to boost throughput, uptime, and repeatability.
• Map process flows and critical control points to enable data-driven decision-making.
• Advance digital transformation through automation, data integration, and Industry 4.0 technologies.
• Use Lean, Six Sigma, and statistical tools to remove bottlenecks and enhance process capability.
• Lead or support root cause analysis and problem-solving for project-specific challenges.
• Execute continuous improvement initiatives focused on safety, quality, and operational efficiency.
• Develop and update SOPs, protocols, and work instructions to align with process and equipment changes.
• Lead NCR/CAPA investigations and drive effective corrective and preventive actions.
• Manage change controls for equipment and process modifications.
• Deliver training and provide ongoing technical support to production teams.
• Act as an SME for equipment troubleshooting and process performance improvements.
• Guide cross-functional teams and vendors while providing technical leadership on complex engineering initiatives.

Requirements

• Bachelor’s degree in Engineering (Mechanical, Chemical, or related field preferred).
• Ability to work in a Penicillin/Cephalosporin facility.
• 5+ years of relevant engineering experience in a manufacturing environment.
• Onsite, full-time role with less than 10% travel.
• Strong understanding of regulatory compliance, safety standards, and validation practices.
• Experience with automation platforms, including:
• Optimize automated systems for high reliability, minimal operator intervention, and stable performance across varying production conditions.
• Reduce human error by simplifying interfaces, designing fail-safes (poka-yoke), and creating processes that naturally guide correct actions.
• Improve alarm systems by eliminating nuisance alerts, prioritizing actionable alarms, and using data to enhance operator response and situational awareness.

Skills

• Technical capability across motion control, VFDs, pneumatics/hydraulics, plus mechanical aptitude.
• Experience with Serialization and SCADA.
• Structured risk-reduction tools (FMEA, failure-mode prevention).
• Industry 4.0 technologies (AI vision, robotics).
• Methodologies like Six Sigma, DFSS, and VOC.

Benefits

Comprehensive compensation and benefits packages including medical and dental coverage, insurance for basic life, accident, short-term and long-term disability, and business travel accident insurance, financial and retirement benefits, and time-off benefits such as paid holidays, paid time off, family and medical leaves of absence, and paid parental leave.