Job Details

Our Work Matters

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

The Impact You Will Make

Looking for an experienced Reliability Engineer that will primarily support Kindeva's state of the art aseptic manufacturing expansion site in Bridgeton, Missouri. This individual will provide support for production equipment and equipment quality compliance by maximizing related uptime and operating efficiencies of equipment and facilities.

Role Responsibilities

• Apply reliability tools, e.g., RCA, RCM, FMEA, statistical analysis, etc.
• Facilitate and lead root cause analysis investigations to eliminate failures using industry-recognized methods.
• Optimizing equipment maintenance strategies based on risk (e.g., PM, PdM, Part availability, TPM, OAC, OEM support).
• Support the capital improvement process for new equipment installations and upgrades by ensuring design-for-reliability and design-for-maintainability concerns are incorporated.
• Develop, maintain, and update maintenance and reliability documentation (e.g., SOP, Preventive Maintenance, KPIs) for critical equipment.
• Develop and implement equipment reliability plans that reduce the number of failures and minimizes the effects of failures that do occur.
• Identify chronic equipment deficiencies and PM gaps through “Bad Actor” analysis and reporting.
• Capture, visualize, and analyze data related to production performance and key performance indicators to facilitate identification of loss, downtime, and opportunities to act to improve overall performance.
• Provide reliability maintenance input to Project Engineering Design and equipment selection through the application of Life Cycle Costing.
• Ability to influence from all levels of the business and work as a valuable team member with colleagues from different backgrounds, cultures, and experience levels.
• Facilitate workshops or cross-discipline teams, driving solutions to reliability problems.

Basic Qualifications

• Minimum – BS in Engineering with 1+ years of related experience in the pharmaceutical industry.
• Working knowledge of Microsoft Project and Smartsheet.
• Prefer knowledge of GMP standards and use of quality systems tools. Prefer prior aseptic experience.
• Must have the ability to simultaneously multitask across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to e-mails and phone communications, and attending multiple meetings and conference calls.
• Experienced in meeting the expectations and requirements of internal and external customers.
• Makes decisions of moderate complexity, sometimes with incomplete information and under tight deadlines and pressure. Makes sound decisions based upon a mixture of analysis, wisdom, experience, and judgment. Always acts with integrity.
• Deals with concepts and complexity comfortably – intellectually sharp, capable, and agile.
• Understands when to inform, consult or escalate. Summarizes information succinctly and accurately and provides clear recommendations based on a combination of the information at hand and regulatory/procedural guidance.
• Review and approve cGMP Changes in accordance with regulatory requirements.
• Review and approve training to assure cGMP requirements are met.
• Understand site financial systems • Understand Safety concerns and maintain safe environment (5S, ergonomics).

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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