Senior Capital Project Engineer

Kindeva Drug Delivery; Bridgeton (MO); On-site; USD 90,000 - 130,000; Full time

Job summary

Kindeva Drug Delivery is seeking a Senior Capital Project Engineer for its Bridgeton, Missouri facility. The role involves leading projects for new product development and maintaining existing products, ensuring all comply with GMP standards and regulatory requirements. Candidates should have a BS in Engineering and extensive experience in the pharmaceutical industry.

Qualifications

• 8+ years of experience in the pharmaceutical industry.
• Ability to work under strict deadlines and multitask.
• Knowledge of cGMPs related to manufacturing of parenteral products.

Responsibilities

• Own and drive implementation of complex, critical projects.
• Develop and maintain project schedules and budgets.
• Conduct routine project review meetings to ensure timelines are met.

Skills

Project Management

Multitasking

GMP Standards Knowledge

Regulatory Compliance

Risk Assessment

Education

BS in Engineering

Tools

Microsoft Project

Smartsheet

Job description

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 role in Bridgeton facility. This position will assume a leadership role to manage projects in support of the development/implementation of manufacturing processes of new products at the site. In addition, this position will also manage projects to maintain existing Auto Injector products to follow regulations and or customer requirements.

Role Responsibilities

• Senior capital engineers will own and drive implementation of complex, critical, and highly visible equipment, production line, and facilities projects.
• Assess risk, develop mitigation plans and to lead regular team meetings working cross functionally with the sites Manufacturing, Quality Assurance, Quality Control, Validation, Technical and Regulatory departments
• Coordinates preparation of all project design documents and bid packages.
• Reviews project design for compliance with engineering principles, company standards, customer contract requirements, and related specifications.
• Develops and maintain the schedule and budget for assigned capital projects, managing from inception through turnover to the project functional owner.
• Responsible for pre-validation efforts for regulatory related projects assigned.
• Provides reporting on planned and approved project schedule to customer, as well as project engineering and site leadership.
• Provides management oversight for all contract resources working on the execution of assigned approved capital projects. This would include productivity, following all safety and quality policies, and appropriate conduct.
• Prepares change control documents where required for assigned projects.
• Approves invoices and complete project close out documentation.
• Determines when work is complete enough to pay suppliers.
• Manages key projects utilizing effective project management tools in order coordinate the introduction of new processes and products into the site.
• Ensures project plans are developed and maintained to meet the needs of the site and customer using appropriate risk mitigation strategies.
• Conducts routine project review meetings with team members to ensure timelines and projected costs are met.
• Ensures that the project teams interact with the sites Validation, Manufacturing, Quality, Technical and Regulatory departments, at appropriate levels, to ensure execution of project tasks.

Basic Qualifications

• Minimum – BS in Engineering with 8 + 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 work effectively under strict production, time and performance deadlines.
• 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.
• Knowledge of cGMPs and regulatory requirements as related to the manufacture, testing and quality of parenteral products.
• Experienced in meeting the expectations and requirements of internal and external customers.
• 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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