Senior Validation Engineer Jobs in Iowa (NOW HIRING)

Company Information
You Matter to Cambrex.
Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients. Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.
Your Work Matters.
At Cambrex, we strive to build a culture where all colleagues have the opportunity to:

• engage in work that matters to our customers and the patients they serve
• learn new skills and enjoy new experiences in an engaging and safe environment
• strengthen connections with coworkers and the community

We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more!
Your Future Matters.
Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today!
Job Overview
As an expert in their field, the Senior Process Engineer leads technical teams responsible for the manufacture of active pharmaceutical ingredients. The senior engineer oversees multi-step, multi-year programs that define the cGMP manufacturing process for active pharmaceutical ingredients. They are an engineering expert, interfacing with internal leadership and external clients to solve complex technical problems and ensure high-quality manufacturing. As a Senior Process Engineer, you will serve as a senior member of our engineering team, taking a leading role in advancing the development and manufacture of active pharmaceutical ingredients. Building on your experience, you'll guide large, multi-year projects that bring complex new medicines from the laboratory to full-scale batch manufacturing, while introducing innovative technologies that enhance our operations.
In this role, you'll mentor and develop junior engineers, helping shape the next generation of talent while receiving mentorship yourself to prepare for senior leadership opportunities - whether as a subject-matter expert or within management. As part of a global contract development and manufacturing organization, you'll collaborate with clients worldwide, tackle technical challenges across diverse processes and unit operations, and make a lasting impact on the success of both our company and the patients who depend on our work.
Responsibilities
• Lead multi-step, multi-year technical programs for the development of the manufacturing process for an API from the initial pilot batches to full commercialization.
• Oversee the conceptual process design for complete API programs including: scaling calculations for unit operations, equipment selection, production planning, and determination of operating parameters.
• Lead process reviews for operability, safety, and quality.
• Operate as a subject-matter expert for external clients and internal stakeholders.
• Mentor junior engineers and scientists.
• Initiate improvements through ideation, process modelling and the analysis of production and laboratory data.
• Lead complex quality investigations and corrective action / preventative action implementation.
• Identify, oversee, and conduct process improvement projects to reduce cycle time, increase yield, and improve quality.
• Coordinate the drafting of manufacturing documents: process flow diagrams, batch records, validation protocols, standard operating procedures, quality investigations, campaign reports.
• Optional Additional Responsibility: Lead a team of 2-5 engineers as direct reports, overseeing career development and project assignments.
Qualifications/Skills

• Applied Math and Science: A complete understanding of the core chemical engineering fundamentals (thermodynamics, heat transfer, mass transfer, transport, kinetics, etc.) and an intuitive sense for their application to real-world problems.
• Data Analysis, Visualization, Troubleshooting: The ability to analyze data from various sources, including sensors and experiments, to identify trends, troubleshoot issues, and improve efficiency.
• Process Simulation and Modeling: Advanced use of software (spreadsheets, programming, simulators) to model chemical unit operations and processes.
• Process Safety and Risk Management: Instinctively assess and manage risks associated with chemical processes, ensuring the safety of personnel and the environment.
• Process Scale Up & Equipment knowledge: Assess equipment capability of key processing equipment (reactors, filters, heat exchangers) with respect to process fit. Proposes alternatives that incorporate business objectives and optimize the use of resources.
• Problem-Solving: Lead discussions and ideation to identify, analyze, and solve complex problems related to chemical processes and plant operations. Includes investigations.
• Technical Writing & Communication: The ability to explain technical concepts clearly and accurately to technical and non-technical audiences.
• Attention to Detail: Be meticulous and pay close attention to detail to ensure accuracy and quality. Review documents and the work of others.
• Adaptability: Adapt to changing priorities, new technologies, and unexpected challenges is important. Assist others with change management.
• Project Management, Leadership, & Mentoring: Manage one's own assignments, delegate, and support others. Manage projects, including timelines, resources, and budgets. Lead teams and mentor junior engineers. Ensure all projects meet the assigned deadlines.

Education, Experience & Licensing Requirements

• B.S. degree in Chemical Engineering or related field.
• 7-15 years of experience in chemical development, chemical manufacturing, chemical engineering design, or the equivalent.
• Experience in a chemical manufacturing environment, particularly pharmaceutical, is preferred

Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration.
All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.
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