Senior Process Engineer I

Kindeva Drug Delivery•Los Angeles, CA

5d•Onsite

About The Position

This Senior Process Engineer role will lead critical, high impact technical initiatives that support inhalation and transdermal drug product manufacturing within a 24/7 commercial facility in Northridge, CA. These initiatives may include process robustness improvements, complex root cause investigations, new product introductions, capacity and yield enhancements, compliance-driven process modifications, and strategic manufacturing optimization efforts.

Requirements

Bachelor's degree in chemical, mechanical, electrical, systems engineering, or other engineering discipline from an accredited institution or a bachelor's degree with manufacturing experience.
5+ years of high speed automated product manufacturing experience is a “MUST” to have.
5+ years in pharma/biotech/medical device manufacturing is preferred.
Expertise in inhalation or transdermal manufacturing is preferred.
Strong familiarity with pharmaceutical industrial process equipment and automated assembly, labeling, and packaging machinery is preferred.
Strong understanding of cGMP, validation, and process controls.
Proven ability to lead investigations and CAPA development.
Experience supporting or leading operations in a 24/7 environment.
Demonstrated ability to successfully execute medium to large and complex projects in support of manufacturing operations.
Ability to successfully lead cross functional teams to achieve project objectives.

Nice To Haves

Master’s degree in a technical discipline.
Experience with Lean Six Sigma, SPC, DOE.
Familiarity with automated systems and MES.
Experience with P&IDs (Piping and Instrumentation Diagrams) and PHA (Process Hazard Analysis) or equivalent.
Experience with high-volume commercial manufacturing or tech transfer.

Responsibilities

Provide on-call and on-site technical support for commercial production lines.
Lead real-time troubleshooting for inhalation and transdermal drug product processes.
Partner with operators and supervisors to rapidly resolve equipment issues and process deviations.
Ensure uninterrupted supply by proactively identifying and mitigating process risks.
Collect and examine basic equipment maintenance problems, facilitating failure analysis for critical equipment (RCA, RCI, FMECA, REM) together with Technical Leaders, generating actions that improve reliability based on field experience and information obtained, considering impact and cost.
Reviews the installation and maintenance plans for new equipment, as well as the necessary basic spare parts
Serve as process owner and technical subject matter experts (SME) for assigned unit operations.
Develop and maintain process control strategies and critical parameter limits.
Drive continuous improvement initiatives (OEE, waste reduction, cycle-time improvements).
Lead scale-up, tech transfers, and validation activities aligned with regulatory guidelines.
Work with our internal clients to modify and/or develop new processes to support new products or improvements to existing products.
Use first principles and process optimization knowledge (DOE) to define scientific approaches to support process improvement. Utilize in depth understanding of materials, process and equipment to improve process robustness and reduce variability.
Identify and drive improvement opportunities.
Support capital projects to create assets and meeting the internal Quality Management System requirements
Author URS, DQR, FAT, Commissioning, SAT, IQ, OQ, and PQ
Lead root cause investigations (OOS, deviations, nonconformances).
Author or approve CAPAs with strong technical justification.
Ensure compliance with cGMP, ISO, and quality system requirements.
Support audits, regulatory inspections, and documentation readiness.
Lead and support Engineering Change Control activities in accordance with FDA regulations and current Good Manufacturing Practices (cGMP)
Mentor junior engineers and provide site-wide subject matter guidance.
Represent Process Engineering in cross-functional forums.
Create a safe and encouraging environment for colleagues to share ideas, contribute and thrive.
Drive innovation in manufacturing methods and analytics.
Stay current with industry trends in inhalation and transdermal technologies