Job Details

Join to apply for the Senior Capital Project Engineer role at Kindeva Drug Delivery

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

The Impact You Will Make

This is an exciting opportunity as a Senior Capital Project Engineer at our Maryland Heights facility. You will lead projects supporting the development and implementation of manufacturing processes for new products and maintain existing Auto Injector products to meet regulations and customer requirements.

Role Responsibilities

• Own and drive implementation of complex equipment, production line, and facilities projects.
• Assess risks, develop mitigation plans, and lead cross-functional team meetings with Manufacturing, Quality Assurance, Quality Control, Validation, Technical, and Regulatory departments.
• Prepare all project design documents and bid packages.
• Review project designs for compliance with engineering principles, standards, and specifications.
• Develop and maintain project schedules and budgets from inception to turnover.
• Manage pre-validation efforts for regulatory projects.
• Report on project schedules to stakeholders.
• Oversee contract resources, ensuring safety, quality, and conduct standards are met.
• Prepare change control documents as required.
• Approve invoices and complete project close-out documentation.
• Manage key projects using effective project management tools.
• Develop project plans with risk mitigation strategies.
• Conduct routine project review meetings.
• Coordinate with Validation, Manufacturing, Quality, Technical, and Regulatory departments to ensure successful project execution.

Basic Qualifications

• Bachelor's degree in Engineering with 8+ years of related experience in the pharmaceutical industry.
• Knowledge of Microsoft Project and Smartsheet.
• Preferably familiar with GMP standards and aseptic processes.
• Ability to work under strict deadlines and multitask effectively.
• Understanding of cGMPs and regulatory requirements for parenteral products.
• Strong customer focus and presentation skills.
• Proficiency in MS Word, Excel, PowerPoint, QTS, Lotus Notes.
• Knowledge of site financial systems and safety protocols.

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

Equal Opportunity Employer

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

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