Manufacturing Engineer

Kindeva Drug Delivery; Simi Valley (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Kindeva Drug Delivery is seeking an engineer to support commercial manufacturing operations in a 24/7 pharmaceutical environment, providing technical support, troubleshooting processes, and engineering deliverables to improve safety, quality, reliability and productivity.

The role covers process ownership, CAPA and change control, project execution, and collaboration with Production, Maintenance, Quality, Validation and Engineering teams; willingness to work across shifts.

Qualifications

• Bachelor's degree in mechanical, electrical, systems engineering, manufacturing or related field.
• 3+ years in pharma/biotech/medical device manufacturing is preferred.
• Knowledge of root cause investigation methodologies and CAPA processes.
• Experience troubleshooting manufacturing processes and equipment.

Responsibilities

• Provide daily technical support for assigned production lines.
• Support troubleshooting of equipment, process, and quality issues.
• Participate in root cause investigations and corrective actions.
• Escalate significant production risks appropriately.
• Support line recovery efforts during downtime events.
• Maintain visibility of online performance and recurring issues.

Skills

Root cause analysis

cGMP knowledge

Project management

Cross-functional collaboration

Troubleshooting

Education

Bachelor's degree in engineering

Tools

MS Office

MES familiarity

Job description

OUR WORK MATTERS

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world

Role Summary

This is a great opportunity to support commercial manufacturing operations within a 24/7 pharmaceutical manufacturing environment by providing technical support, troubleshooting processes, continuous improvement, and project execution. This individual will be supporting assigned production lines, driving corrective actions, and executing engineering deliverables that improve safety, quality, reliability, and productivity.

Role Responsibilities

Manufacturing Support (24/7 Facility)

• Provide daily technical support for assigned production lines.
• Support troubleshooting of equipment, process, and quality issues.
• Participate in root cause investigations and corrective actions.
• Escalate significant production risks appropriately.
• Support line recovery efforts during downtime events.
• Maintain visibility online performance, downtime losses, and recurring issues

Process Ownership & Optimization

• Serve as engineering owner for assigned manufacturing processes.
• Manage assigned action items and corrective actions to closure.
• Support OEE, uptime, yield, scrap reduction, and throughput improvements.
• Develop and implement process improvements.
• Support validation, qualifications, and change-control activities.
• Maintain technical documentation and engineering records

CAPA, Quality, and Compliance

• Support investigations, deviations, and CAPAs.
• Complete assigned quality actions by committed due dates.
• Maintain compliance with cGMP requirements.
• Support audits and inspection readiness activities.
• Participate in Engineering Change Control processes)

Project Execution

• Execute assigned engineering projects and deliverables.
• Manage multiple assignments simultaneously.
• Communicate project risks and delays proactively.
• Meet agreed-upon completion dates.
• Provide regular status updates to management.
• Support implementation of capital and continuous improvement projects

Qualifications

Required

• Bachelorucky's degree in mechanical, electrical, systems engineering, manufacturing or other engineering discipline from an accredited institution or a bachelor’s degree with manufacturing experience.
• 3+ years in pharma/biotech/medical device manufacturing is preferred.
• Working knowledge of root cause investigation methodologies and corrective action development.
• Working knowledge of cGMP requirements, quality systems, change control, deviations, and CAPA processes.
• Experience troubleshooting manufacturing processes, equipment, and production issues.
• Ability to manage multiple assignments and priorities simultaneously.
• Demonstrated ability to execute engineering projects from concept through implementation.
• Strong written and verbal communication skills.
• Experience supporting manufacturing operations in a production environment.
• Proficiency with Microsoft Office applications and engineering documentation systems.
• Ability to work effectively with Production, Maintenance, Quality, Validation, and Engineering teams.
• Willingness to provide support within a 24/7 manufacturing operation when business conditions require additional engagement.

Preferred

• Familiarity with automated systems and MES.
• Experience with Lean Manufacturing, Six Sigma, DMAIC, Kaizen, SPC, or DOE methodologies.
• Experience participating in equipment qualifications, validations, and commissioning activities.
• Familiarity with RCAs, CAPAs, deviations, and investigation systems.
• Experience supporting OEE, downtime reduction, scrap reduction, and productivity improvement initiatives.
• Expertise in inhalation or transdermal manufacturing is preferred.

California residents should review our Notice for California Employees and Applicants before applying.

Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.

The expected compensation range for this position represents a good faith estimate. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental, & Vision, Health Savings Accounts, Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences, and 401k Benefits, etc.).

Equal Opportunity Employer

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

Do you see yourself as part of the Kindeva mission?