Capital Project Engineering Manager

2 weeks ago

Wichita, United States Fagron Gmbh & Co. Kg Full time

Capital Project Engineering Manager - Tech Services

About the job About the role As a Capital Project Engineering Manager at Fagron Sterile Services, you will play a pivotal role trough conception, designing, and managing the successful execution of capital projects, with a specific focus on cGMP compliance and increased efficiencies. You will be responsible for ensuring that all capital projects related to facility expansions, equipment installations, process improvements, and infrastructure upgrades adhere to cGMP guidelines and meet regulatory requirements. This position requires a thorough understanding of project management practices, good engineering practices, and the ability to coordinate cross-functional teams to deliver projects on time and within budget.

Key Responsibilities • Lead and manage capital projects from initiation to completion, ensuring compliance with cGMP regulations and internal quality standards. • Mentor and develop junior project manager aligning with good engineering practices and Fagron quality standards. • Develop project plans, including scope definition, objectives, milestones, timelines, budgets, and resource requirements. • Collaborate with cross-functional teams, including manufacturing, quality, supply chain, and other relevant stakeholders, to define project requirements and ensure alignment. • Conduct risk assessments and develop mitigation strategies to address potential compliance and quality issues. • Establish and maintain effective communication channels with stakeholders, providing regular updates on project status, risks, and mitigation plans. • Monitor project progress, identify deviations from plans, and implement corrective actions as necessary to ensure on-time and on-budget project delivery. • Coordinate procurement activities, including vendor selection, negotiation, and management of contracts, ensuring adherence to cGMP requirements. • Work closely with Validation writing and executing qualification activities associated with capital projects, ensuring compliance with cGMP guidelines. • Develop and maintain project documentation, including project charters, project schedules, budgets, risk registers, and change control processes. • Participate in regulatory inspections and audits, providing documentation and supporting evidence to demonstrate compliance with cGMP regulations. • Contributor during semi-annual shutdowns • Other projects and duties as required. Set yourself apart Basic Qualifications • Bachelor's degree in engineering, project management, or a related field. • A minimum of four years of experience in capital project management within the pharmaceutical, biotechnology, or related industry, with a strong focus on cGMP. • In-depth knowledge of cGMP regulations, guidelines, and industry best practices. • Proven track record of successfully managing complex capital projects from initiation to completion, ensuring compliance with cGMP requirements. • Demonstrate reliability in attendance and punctuality. • Self-motivated and customer centric. • Experience with Microsoft applications (Outlook, Excel, Word)

Core Competencies • Project Management: Demonstrated ability to plan, execute, and control capital projects, including developing project plans, managing resources, monitoring progress, and implementing corrective actions. • cGMP Compliance: Thorough understanding of cGMP regulations and experience in maintaining compliance throughout capital projects, ensuring adherence to quality standards and regulatory requirements. • Cross-functional Collaboration: Strong interpersonal skills and the ability to work effectively with diverse teams, coordinating efforts, and aligning stakeholders towards project objectives. • Risk Management: Proficiency in identifying project risks, conducting risk assessments, and developing appropriate mitigation strategies to ensure compliance and project success. • Communication: Excellent verbal and written communication skills, with the ability to clearly convey complex information to both technical and non-technical stakeholders. • Problem Solving: Strong analytical and problem-solving skills, with the ability to identify issues, evaluate options, and make sound decisions in a fast-paced environment. • Attention to Detail: Meticulous approach to project management, ensuring accuracy, quality, and compliance throughout the project lifecycle. • Adaptability: Ability to thrive in a dynamic and changing environment, effectively managing priorities and adjusting project plans as necessary. What’s on offer? We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional, and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry. Share this job opening: "We are always looking for the best minds to deliver high-level performances." Would you like to be considered for a future position that matches your profile and career objectives?

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