Lead Process EngineerWe are seeking a
Lead Process Engineer to join our site engineering team in Alabaster, Alabama. This technical leadership role is accountable for improving manufacturing performance across pilot plant, clinical and commercial drug substance manufacturing operations. The role owns the site process optimization roadmap and leads initiatives to reduce process variation, increase yield, improve gross margin, reduce cycle times, expand capacity and strengthen operational effectiveness.
The Opportunity In this role, you will serve as the senior engineering partner to Manufacturing, Manufacturing Science & Technical Services (MS/TS), Quality, Reliability Engineering and Supply Chain. You will provide governance and prioritization for process improvement initiatives, oversee the site Operational Excellence portfolio, lead minor capital projects, and act as the primary escalation point for complex technical manufacturing issues.
Who We're Looking For Education and Certification - Bachelor's, master's or doctoral degree in Chemical Engineering.
- Lean Six Sigma Black Belt certification.
Required Experience - 10 years of experience in a regulated environment.
- General knowledge of pharmaceutical product or excipient manufacturing processes.
- Experience developing and implementing business strategies, including organizational structure, change management, budget development, project management and strategic staffing plans.
- Experience applying technical expertise, data analysis and root cause evaluation to resolve complex manufacturing and process issues.
- Knowledge of safety and environmental compliance regulations and practices for working around hazardous chemicals.
Skills and Capabilities - Excellent leadership, mentoring and team development skills.
- Excellent written and verbal communication skills, with the ability to interact effectively with employees, customers and senior management.
- Ability to identify unanticipated outcomes or deviations and rapidly develop appropriate corrective actions.
- Ability to improve policies, practices, procedures, engineering standards and systems.
- Knowledge of PPE, safety protocols and practices related to potential airborne exposure to hazardous chemicals.
What You'll Be Doing Process Engineering Leadership - Lead and coordinate the Process Engineering function, establish annual objectives and maintain improvement roadmaps.
- Prioritize engineering resources and improvement projects based on business requirements and expected impact.
- Develop engineering standards, best practices, systems and processes.
- Mentor process engineers and serve as the senior technical escalation point for manufacturing process performance issues.
Manufacturing Performance and Cost Improvement - Own site-level performance and improvement programs for yield, gross margin, cycle time, throughput, process capability, cost reduction, overall equipment effectiveness and right-first-time performance.
- Identify losses and performance gaps, analyze trends, recommend actions, establish improvement targets and monitor effectiveness.
- Identify opportunities to improve gross margin and overhead allocation through yield improvement, waste reduction, solvent recovery and removal optimization, energy reduction, labor productivity and equipment utilization.
- Quantify financial benefits, build business cases and report savings generated through implemented improvements.
- Provide regular updates to MS/TS, Engineering and Operations leadership.
Cycle Time Reduction and Capacity Improvement - Perform value-stream analyses to identify bottlenecks and production constraints.
- Improve equipment utilization, changeover efficiency, batch cycle times, process throughput and scheduling effectiveness.
- Support debottlenecking initiatives and capacity expansion plans.
- Partner with Production to improve schedule adherence and operational execution.
Plant Support and Minor Capital Projects - Own the site's five-year portfolio of process-related capital projects and prioritize projects based on safety, compliance, capacity, cost, growth and value preservation.
- Lead multiple minor capital projects, typically less than $1 million each, from scope development and funding requests through startup and closeout.
- Develop project scopes, estimates, engineering justifications and schedules; coordinate contractors, vendors, Operations and Quality.
- Review and approve project scope changes and ensure projects achieve objectives related to capacity, reliability, cost reduction, safety, compliance and technology upgrades.
- Support commissioning and Operational Readiness Reviews, and lead engineering activities related to equipment qualification, commissioning, startup and requalification.
- Develop and execute risk assessments, impact assessments and qualification protocols.
Process Hazards and Risk Management - Lead and facilitate process hazard analyses, HAZOPs, What-If reviews, job safety analyses and Management of Change activities.
- Identify process safety risks, implement engineering controls and ensure process modifications maintain acceptable safety and regulatory compliance.
- Support Process Safety Management and site safety initiatives.
Master Batch Record Stewardship - Serve as a key technical owner for governance and compliance of master batch production records (MBPRs).
- Partner with MS/TS, Production and Quality during new product introduction, scale-up, technology transfer and process improvements.
- Ensure batch documentation accurately reflects current process design and control strategies.
Continuous Improvement and Operational Excellence - Lead site process optimization strategies and facilitate Lean Manufacturing and Operational Excellence initiatives.
- Develop long-term improvement pipelines and project portfolios.
- Partner with Production leadership to improve operations and drive engineering solutions that reduce variability and improve process robustness.
Working Conditions - This is a site-based role located in Alabaster, Alabama.
- The role works in a laboratory and manufacturing environment and may involve contact with organic solvents, biological samples and caustic chemicals.
- The position is active and requires standing, walking, bending, kneeling and stooping. Occasional lifting or moving of items up to 50 pounds is required.
- Occasional business travel to Croda and contractor sites in the United States and internationally may be required.
What We Offer Join a global organization with opportunities for growth, technical leadership and meaningful impact. The successful candidate will receive a competitive salary and benefits package including:
- Excellent Medical, Dental and Vision coverage, available immediately.
- Generous PTO and paid holidays.
- Career development opportunities.
- Company-paid and voluntary Life and AD&D Insurance.
- Short- and long-term disability.
Additional Information This on-site position is located in
Alabaster, Alabama.If you require any reasonable adjustments during the hiring process or experience any issues with our online application process, please email [redacted].
