Job Description
Senior Automation Manager Posting
Our Work Matters
At Kindeva, we make products that save lives, ensuring better health and well-being for patients around the world.
Why Kindeva?
• Purpose-driven work environment
• Significant growth potential
• Collaborative team culture
• Direct impact on patient care
• Industry-leading innovation
At Kindeva, we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make:
Lead the Future of Pharmaceutical Automation. Join a growing pharmaceutical CDMO where your leadership will establish and standardize automation strategy across three manufacturing sites with varying levels of automation maturity. As the Senior Automation Manager, you will serve as the enterprise automation leader responsible for building a scalable, sustainable automation program that supports operational excellence, regulatory compliance, and long-term organizational growth.
In this role, you will lead automation strategy for new facility stand-up, fill-finish and supporting equipment, automated visual inspection systems, auto-injector and device assembly automation, and packaging and serialization integration. You will oversee full lifecycle system ownership—from specification and implementation through validation and commercialization—while combining deep pharmaceutical automation expertise with strong organizational leadership to develop a high-performing automation function and future automation talent across the enterprise.
Responsibilities:
Enterprise Automation Strategy
• Develop and execute a multi-year automation roadmap across three sites.
• Standardize controls architecture, PLC/HMI platforms, data systems, and automation governance.
• Establish a robust lifecycle management program aligned with GAMP and regulatory expectations.
• Lead modernization initiatives for legacy systems while ensuring minimal operational disruption.
New Facility & Capital Project Leadership
• Lead automation strategy for major expansion projects.
• Own development and oversight of URS, FS, DS, FAT/SAT, commissioning, qualification, and PPQ support.
• Drive seamless integration from equipment procurement through validated commercial launch.
• Provide technical oversight during capital justification and vendor selection processes.
Automation Domain Expertise
• Provide subject matter expertise in one or more of the following areas, with the ability to support or develop capability in others over time:
• Automated visual inspection (AVI) for syringes and vials
• Cosmetic and particulate detection technologies
• Reject management and data capture systems
• Ensure systems meet applicable regulatory and data integrity expectations.
Device Assembly & Combination Product Automation
• Support or lead automation activities related to auto-injector and/or device assembly systems, which may include:
◦ Component feeding and orientation
◦ Needle safety system integration
◦ Plunger rod insertion and final device assembly
◦ Functional device testing (force, timing, deployment verification)
◦ Traceability and tamper-evident integration
• Ensure alignment with applicable combination product regulatory requirements.
Packaging, Serialization & Inspection Systems
• Provide automation support and/or leadership for packaging and serialization systems, including:
◦ Multi-carton configurations
◦ Blister packaging
◦ Specialty packaging for combination products
◦ Serialization and aggregation (unit through pallet)
• Ensure compliance with global track-and-trace requirements (e.g., DSCSA, EU FMD) as applicable.
• Support integration of packaging and serialization systems with site and enterprise data platforms.
Lifecycle & Commercialization Ownership
• Provide automation leadership or support across the project lifecycle from concept through commercialization.
• Partner with Validation and Quality to ensure compliant IQ/OQ/PQ execution.
• Drive automation reliability, performance monitoring, and OEE optimization.
• Implement structured change control and digital lifecycle documentation practices.
Multi-Site Collaboration
• Support harmonization of automation standards across sites, with opportunities to contribute to broader multi-site initiatives.
• Collaborate on spare parts strategies and obsolescence planning.
• Provide technical input and support for critical automation events as needed.
• Contribute to modernization planning based on business and operational priorities.
Organizational Development & Talent Strategy
• Lead, mentor, or support automation engineers and technical teams, depending on project scope and organizational needs.
• Contribute to onboarding, training, and development of team members.
• Support knowledge sharing and cross-training to strengthen team capability.
• Participate in building a sustainable support model for both capital projects and ongoing operations.
Compliance & Data Integrity
• Ensure compliance with:
◦ 21 CFR Part 11
◦ Annex 11
◦ GAMP 5 lifecycle standards
◦ Combination product regulatory guidance.
• Maintain audit readiness across automation systems and digital infrastructure.
• Partner with IT/OT to strengthen cybersecurity and system resilience.
Qualifications:
Required
• Bachelor’s degree in Engineering or related technical field required; Master’s degree preferred.
• 7+ years of progressive experience in regulated manufacturing (pharma, med device, biotech)
•
• Demonstrated success leading automation in one or more of the following: fill finish, device assembly, packaging, automated inspection, or serialization.
• Strong Expertise in at least (one /two )major automation domain and familiarity with others
Core Competencies
• Pharmaceutical fill-finish automation
• Combination product and device assembly automation
• Packaging & serialization integration
• PLC, SCADA, HMI, MES architecture
• Lifecycle validation and data integrity
• Multi-site standardization
• Organizational development & succession planning
• Strategic capital execution
Join our One Team mission of manufacturing more tomorrows. Your expertise will help ensure better health and well-being for patients worldwide.
# LI-Onsite
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.
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.
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