Process Engineer – Fill-Finish SME (Hybrid)

Company Description

CRB's over 1,500 expert professionals drive innovative, life-changing and life-saving solutions for manufacturers in the life sciences and food and beverage industries. Our mission, vision, and core values put client satisfaction and employee experience at the center of everything we do.

As an AEC Firm we proudly specialize in industries that inherently carry important social responsibility - we recognize our impact and influence in the communities we serve and pursue corporate responsibility through the lens of people, community, and planet. From oncology and rare disorders to COVID-19 or alternative proteins, our design and construction projects are pioneering solutions addressing important issues such as food scarcity and global health.

Job Description

As a Process Engineer Subject Matter Expert (SME) in Fill-Finish you will possess rare and exceptional technical knowledge, coupled with general industry knowledge and experience. 

How will I contribute?

You will provide value to clients during project sponsorship and inception to ensure that the investment supports the business goals and accounts for constraints and external risks. You will provide guidance for developing Lead and Senior Engineers to help identify and manage technical risks during execution and delivery. You will reinforce trust in the institution by leading participation in industry groups, publishing technical articles, presenting novel and compelling content at industry events and bolstering the company profile on critical must-win projects.

Responsibilities 

• Gather process data and developing project requirements.
• Develop design criteria for Fill-Finish lines.
• Direct development of equipment lists for complex processes.
• Direct development of detailed process description narratives, process flow diagrams, and P&IDs.
• Work directly with facility planners to layout the process needs including space, adjacencies, and flows.
• Research equipment providers and make recommendations and selections based on client and project requirements.
• Write process equipment specifications for complex equipment.
• Write testing requirements and attending factory acceptance tests (FATs) for equipment.
• Follow projects after construction documents are issued and reviewing submittals, answering RFIs, and making field visits to verify progression of process scope is proceeding per the intent of the design.
• Perform HAZOP reviews and project quality reviews.
• Be a mentor and provide training to Process engineers.
• Develop and present continuing education topics internally.
• Represent CRB with external partners and clients and develop key relationships throughout the industry including participation in industry organizations, writing papers/articles, and speaking and presenting.
• Staying abreast of the latest technologies used in our industry and being aware of the approximate costs of the various technologies that could be used to solve our clients’ design challenges.
• Establishing CRB as a thought leader throughout the industry such that additional project opportunities become available.

Qualifications

• Degree in Chemical or Mechanical Engineering preferred
• 15 plus years of experience required, much of this preferably in a design firm setting
• Professional Registration a plus
• Expert in developing process strategies/philosophies for Fill-Finish projects
• Expert in FDA, EMA, and other regulatory standards and requirements for Fill-Finish processes       
• Advanced knowledge and application of cGMP in Fill-Finish applications required
• Proven ability to present process designs to existing and new clients required
•  Proven ability to lead a project and to direct the process design effort required 
• Proven ability to author articles and to present at conferences required
• Experience with MS Office products especially Word, Visio and Excel required
• Ability to direct Fill-Finish design activities and lead a team of engineers required

Additional Information

The pay range for a candidate selected for this position who is based in Colorado is typically $128,000 to $258,000 annually. The base salary range represents the low and high end of the salary range for this position. The selected candidate’s actual pay will be based on various factors, including but not limited to work location, qualifications, and relevant experience. In addition, CRB offers a total rewards package that includes comprehensive insurance coverage as well as the opportunity to participate in one or more annual incentive programs based on company and individual performanc