Job Description

Job Description

Holly Springs, NC - Project Engineer II through III 

LET’S TALK ABOUT CULTURE 

Are you ready for a culture that you deserve? We are ready for you. At Concuir, our team consciously executes a culture of Life/Work Integration. Leaders promote full psychological safety in the workplace to allow you to bring your full self to work every day. Our team members enjoy their work with increasing creativity, productivity, and team collaboration. This ultimately raises the bar on the services we deliver, client’s results, and treatments that make their way out to patients. Let’s grow and succeed together! 

Are you a motivated, proactive, positive, team player? Do you have experience in the Life Science industry and want to learn and grow? Joining Concuir is a great way to utilize and enhance your technical project engineering skills while fulfilling your career and personal goals for your own definition of success. 

Associate Consultant - Project Engineer II through III  

Compensation package is annual salary ($85,000-$110,000 DOE) plus quarterly bonuses (3-10% of salary target, depending on performance). 

JOB DESCRIPTION: 

As a full-time employee of Concuir, Inc, you will provide consulting services to pharmaceutical and/or biotech manufacturing clients. In this role, you will quickly learn common client practices, recommend, and implement improvements to reach project goals and have the opportunity to scale-up and bring new products into manufacturing. You will be able to utilize your experience as well as benefit from Concuir’s portfolio of project management and cGxP best practices to drive your overall success. Projects range from design through qualification of production equipment, utilities modification, implementation of new facilities and process scale ups. In this initial project, you will provide project engineer support in executing on delivering drug product unit operations.  

• You will drive to understand our unique client needs to deliver successful results. Providing excellent customer service to our clients and ultimately the patients they serve is critical. Your Concuir leadership will work with you to guarantee internal processes and support are in place to ensure your positive results. 
• You will execute projects day-to-day for your clients with mentorship and technical problem-solving collaboration from your manager and team. 
• You will interface with process owners and project stakeholders to reach our clients' objectives. This includes resolving critical issues and gathering appropriate feedback from the team. 
• Depending on scope and project complexity, you may be responsible for delivering between 1 and 3 projects concurrently. 

RESPONSIBILITIES: 

• Deliver on client expectations and maintain strong stakeholder communication throughout the project life cycle. 
• Perform Capital and/or Expense project deliverables in alignment with project timelines, budgets and objectives. 
• Facilitate team communication and accountability by escalating issues appropriately. 
• Participate in cross functional teams dedicated to process improvement, efficiency, and optimization. 
• Support technology transfer, construction activities, and scale-up efforts with strong technical documentation and writing.  
• Provide technical assessments for investigations, validation, and change control. 
• Review vendor submittals and technical documentation to ensure alignment with project design and user requirements. 
• Coordinate with project partners during equipment installation to ensure readiness and adherence to design intent. 
• Participate in troubleshooting and start-up of Process Equipment and Utilities. 
• Support Factory Acceptance Testing (FAT) activities, including participation, documentation review, and issue resolution. 
• Generate and revise engineering specifications to support process equipment and manufacturing operations. 
• Execute studies and comparability protocols to manufacturing operations. 
• Contribute to turnover package (TOP) documentation to support project close-out requirements. 
• Assist with deviation management and change request documentation as part of project execution. 
• Execute studies and comparability protocols to manufacturing operations. 
• Participate in troubleshooting and start-up of Process Equipment and Utilities. 

QUALIFICATIONS: 

• 3-7+ years' experience working on capital or expense projects in Pharmaceutical, Biotech or Medical Device industries. 
• BS in Engineering degree required (Chemical, Mechanical, Biomedical, or related). 
• 3+ years of experience in a cGMP environment required. 
• Experience with equipment installation, commissioning, FAT/SAT, or C&Q. 
• Self-starter with strong communication skills, both verbally and written. 
• Ability to work with and build good relationships with stakeholders and the wider site teams. 
• Ability and desire to work within a high-performing team and collaborate effectively and respectfully with internal and external staff at all levels and of diverse backgrounds. 
• Previous consulting or owner side-project experience preferred. 
• Ability to work up to 100% on-site at client facilities. 
• Willingness and ability for up to 25% travel.

OUR PURPOSE: 

Be a recognized leader in cGxP project strategy and delivery for the pharma and biotech industry. 

OUR MISSION: 

To Improve the lives of our people, clients, and patients. 

“We make the lives better of people who make lives better TM”   

OUR PROMISE TO YOU: 

“You will learn, grow, and further your life and career goals working with us” 

WHAT WE VALUE:  

• We believe that we are better together: We seek to understand employees’ unique interests, skill set, style, and approach to ultimately add value to our whole team and individual’s well-being. 
• We are committed to learn and grow: We continually challenge ourselves to expand our knowledge and experience. We seek meaningful opportunities and use proven processes to develop our high performing team for the benefit of our customers. 
• We believe top performers get top results: We recruit and hire talented consultants that enjoy working for numerous clients on a variety of projects. 
• We Value our Employees: Every person has interests, goals, dreams, and a unique outlook and input. We actively collaborate with timely multidirectional collaboration. We work together to achieve individual, as well as team and company, goals so that we are all growing and succeeding together. We believe that Life & Work Integration allows the achievement of life goals with everyone achieving complete success. 
• We work to benefit our customers and ultimately the patients they serve: We look to work with customers that provide life-saving and life improving therapies and we work to add value to both our clients and the pharma, biotech and medical device industry. 

WORKING WITH CONCUIR, INC: 

Mission driven leadership is essential to Concuir, Inc. Our leaders set an example and inspire those they work with. They make time for people and take a sincere interest in them. They prioritize the opportunities to learn and grow with them while showing respect and appreciation. 

We embrace our mission and our leadership culture by challenging ourselves to identify issues that are most important for our clients, our team and our community. 

Concuir, Inc is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.  

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