Jobs at Kindeva

• Defines and implements a Quality Operations Program
• Leads and manages the Quality Operations department, including a team of direct reports.

• Support routine Veeva Vault administration activities, including user account maintenance, role assignments, group membership updates, and access request processing in accordance with approved procedures.
• Assist with configuration updates for document types, metadata, workflows, lifecycle states, te...

• Lead complex capital projects from concept through startup, including scope development, project justification, engineering design, procurement, construction, commissioning, and operational handoff.
• Develop project business cases, capital requests, budgets, schedules, and funding strategies while maintaining accountability for project cost, cash flow, and overall financial performance.

• The mission of Automation is to provide highly effective automated manufacturing workflow solutions, information collection systems, and reporting solutions for the St. Louis facilities.
• Provide technical expertise required to achieve and sustain optimum reliability, maintainability, useful life, and life cycle cost for all facilities, manufacturing, utilities, and process systems/assets .

• Own end-to-end technical administration of D365 Finance & Operations across Dev, Test, UAT, and Production environments.
• Manage LCS (Lifecycle Services) activities including environments management, monitoring, updates, deployments, hotfixes, and Microsoft escalations.

• Lead complex, cross-functional projects from initiation through implementation, ensuring alignment with strategic business objectives and successful delivery of measurable outcomes, including cost, capacity, service, quality, and compliance.
• Partner with business leaders early in project development to define scope, assumptions, timeli...

• Purpose-driven work environment
• Significant growth potential

• Develop, implement, and oversee a capital spend program, aligning with the company’s strategic objectives and budgetary constraints.
• Monitor capital expenditures and ensure efficient allocation of resources across multiple projects.

• Execute and support qualification activities for laboratory instruments, and computerized systems, including IQ, OQ, requalification, and periodic review activities; ensuring laboratory equipment and systems remain compliant with GMP requirements, FDA regulations, Data Integrity expectations, and internal quality systems.

• Act as the primary SME for aseptic manufacturing equipment, utilities (WFI, clean steam, compressed gases), and fill-finish systems (vial washers, depyrogenation tunnels, isolators/RABS, filling lines, cappers, lyophilizers, robotic systems, etc.).
• Provide technical leadership for aseptic fill/finish operations, including process design, scal...

• Leads or participates in design control, change management and risk management activities related to the combination device, design and manufacturing process ensuring compliance to all applicable regulations including FDA Regulation and Guidance for Combination Products
• Perform Quality Risk Assessments

• Act as key technical lead for process development. Independently design and manage studies for process development, process optimization, scale-up, manufacturing records and technology transfer.
• Serve as the technical lead for sterile injectable visual inspection, assembly, labeling, and packaging process validation activities, including equipment qualification support, process characterization, and continued process verification.

• As a member of the Site Leadership Team (SLT), sets goals for both site and function.
• Provides direction and prioritization for the functional area managers within the F&E department. Hires and develops employees and creates succession plans. Provides feedback and coaching, and performance management.

• Partner primarily with the Bridgeton site leadership to deliver financial guidance, operational insights, and practical decision support aligned with site and business unit priorities.
• Build strong working relationships across operations, development, supply chain, engineering, and project management teams.

• Purpose-driven work environment
• Significant growth potential

• Provide FP&A support to global executive leaders. Drive project prioritization, headcount resource allocation, and budget management.
• Develop reporting through existing tools and implementation of new reporting technology and improved automation. Design, implementation and system maintenance of performance management tools

Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world.

• Plan and execute technology transfer activities for drug products or devices from R&D to manufacturing or between commercial sites
• Author and/or review tech transfer documentation (e.g., process descriptions, gap assessments, risk assessments, readiness assessments, protocols)

• Primary Quality Contact for their products
• Responsible for reviewing and approving investigations for their products and, collaborating with key stakeholders and customers to ensure investigations are closed in a timely manner.

• Develop and execute a multi-year automation roadmap across three sites.
• Standardize controls architecture, PLC/HMI platforms, data systems, and automation governance.