Senior Capital Project Engineer

Kindeva Drug Delivery; Missouri; On-site; USD 90,000 - 130,000; Full time

Job summary

A leading pharmaceutical company, Kindeva Drug Delivery, is seeking a Senior Capital Project Engineer for its Bridgeton facility. This individual will take charge of managing critical projects aimed at developing and implementing manufacturing processes of new products, ensuring compliance with regulations. Ideal candidates will have robust engineering experience and a strong background in project management within the pharmaceutical sector.

Qualifications

• Minimum 8+ years of experience in the pharmaceutical industry.
• Working knowledge of GMP standards and quality systems.
• Ability to manage multiple competing priorities simultaneously.

Responsibilities

• Own and drive implementation of complex and critical equipment projects.
• Lead risk assessment and develop mitigation plans.
• Coordinate preparation of all project design documents.

Skills

Project Management

Risk Assessment

Communication

Multitasking

Technical Compliance

Education

BS in Engineering

Tools

Microsoft Project

Smartsheet

MS WORD

Excel

PowerPoint

Job description

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

3 days ago Be among the first 25 applicants

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

Our Work Matters

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

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

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.
• Presentation skills, computer literate (MS WORD, Excel, PowerPoint, QTS, Lotus Notes).
• Understand site financial systems
• Understand Safety concerns and maintain safe environment (5S, ergonomics).
  
  

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 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.

Do you see yourself as part of the Kindeva mission? Click Apply Now Today!

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Engineering and Information Technology

• Industries

  Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at Kindeva Drug Delivery by 2x

Get notified about new Senior Project Engineer jobs in St. Louis County, MO.

Facilities Electrical Engineer (Experienced or Senior)

Senior Project Manager, Food & Beverage Manufacturing

Clayton, MO $93,000.00-$189,000.00 1 week ago

Bridgeton, MO $55,055.00-$105,875.00 6 days ago

Production Project Manager for our Kansas City branch

Allenton, MO $55,000.00-$65,000.00 2 weeks ago

Bridgeton, MO $113,740.00-$176,581.00 4 hours ago

Electrical Project Engineer/Senior Electrical Designer

Maryland Heights, MO $80,000.00-$103,000.00 12 hours ago

Senior Electrical Engineer Industrial Manufacturing

St. Louis County, MO $145,000.00-$165,000.00 1 week ago

Chesterfield, MO $150,000.00-$180,000.00 1 week ago

Senior Structural Engineer - Technical Manager

Electrical Engineer Support Equipment Technician (Mid-Level or Senior)

Maryland Heights, MO $52.00-$58.00 1 week ago

Project Engineering Manager - Water/Wastewater

Electrical Systems Safety Engineer (Mid-Level, Senior, Principal)

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.