Senior Process Engineer – Sterile Fill-Finish

About Us:

BW Design Group is a fully integrated architecture, engineering, construction, system integration, and consulting firm committed to helping our clients realize their most critical goals from Strategy to Commercialization. As the only firm born from a manufacturing technology company to become an independent and fully integrated firm, we combine deep domain expertise in the manufacturing environment with an approach that is built to serve the dynamic needs of our clients. Rooted in our distinct culture of Truly Human Leadership, we cultivate the leaders who will define tomorrow and partner with our clients in the food & beverage, life sciences, industrial, and advanced technology industries to build the future of manufacturing and technology.Barry-Wehmiller is a diversified global supplier of engineering consulting and manufacturing technology for the packaging, corrugating, sheeting and paper-converting industries. By blending people-centric leadership with disciplined operational strategies and purpose-driven growth, Barry-Wehmiller has become a $3 billion organization with nearly 12,000 team members united by a common belief: to use the power of business to build a better world.

Job Description:

You will join one of our 45 offices in the US, be part of a committed team of over 1500 professionals, and work in teams and directly with our clients doing work that is shaping the world around us. You will be welcomed into a rapidly growing business and team and empowered to make an impact. You will be valued, cared for, and challenged on your path to becoming a world-class professional consultant and surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment.

When you join Design Group as a Process Engineer, you are joining a team that will challenge you and position you for growth. In this role, you will work with a team of industry experts to help the world’s leading companies solve their most difficult problems. You will partner with seasoned leaders, technical specialists, and subject matter experts to deliver the highest quality solutions to our clients with consistency and accuracy.

Responsibilities:
Design Group is looking for Engineers with significant experience in one of the following processes:

• Aseptic Filling
• Lyophilization
• Visual Inspection
• Biocontainment

The Process Engineer role is a key member of the Life Science Team with responsibilities beginning with initial client contact, developing early stakeholder (client) alignment based on relationships built on technical competency, proactive client engagement and development of innovative solutions. You will serve as a consulting engineer and technical lead supporting pharmaceutical and biotech clients on aseptic filling, lyophilization, biocontainment systems, or visual inspection capital projects. The role will span the entire project lifecycle from basic and detailed design through procurement, construction, commissioning, and startup activities of the systems & equipment that you will be directly responsible for. In addition to working on these project lifecycle phases, you will be expected and responsible for performing technical activities, which would include supporting one of the following roles:

Aseptic Filling:

Responsible as a process expert for Aseptic Filling systems and processing operations, regulatory guidance trends, evolving technology innovations, OEM supplier community partner, with contributions from early design through commissioning and startup activities within the system lifecycle.

Prior experience supporting vial and syringe filling lines with integrated isolator and/or RABS systems, CIP & SIP systems, and utility supply to sterile processes. Ability to participate in system design discussions and workshops with client, design-build firms, and OEM. Firm understanding of aseptic processing and contamination control strategies. Ability to develop user requirement specifications, review equipment layouts, and work with OEM directly on design changes, procurement activities, and commissioning, startup, and handover. Collaborate with quality and CQV teams on equipment qualification, process validation, and regulatory readiness.

Experience with high-potent aseptic processing and BSL categorization is a plus.

cGMP & Regulatory Compliance: Deep understanding of FDA (CFR)/EMA regulations (USP, Annex 1), FDA Guidance (Sterile Drug Products Produced by Aseptic Processing, Process Validation), ICH guidelines, ISO 13408 and 14644, PDA Technical Reports (29, 60, 64, and 90)

Visual Inspection:

Responsible as a process expert for Visual Inspection systems, regulatory guidance trends, evolving technology innovations, OEM supplier community partner, with contributions from early design through commissioning and startup activities within the system lifecycle.

Prior experience supporting manual, semi-automated, and automated visual inspection operations with integration into camera-based vision technologies. Ability to participate in system design discussions and workshops with client, design-build firm, and OEM. Solid understanding of inspection and defect classification strategy development with sound statistical rationale that meets regulatory standards. Ability to develop user requirement specifications, review equipment layouts, and work with OEM directly on design changes, procurement activities, and commissioning, startup, and handover. Collaborate with quality and CQV teams on equipment qualification, process validation, and regulatory readiness.

cGMP & Regulatory Compliance: Deep understanding of FDA (CFR)/EMA regulations (USP 790 and 1790, Annex 1), FDA Guidance (Container Closure Systems for Packaging Human Drugs, Process Validation), ICH guidelines, ISO 13408, PDA Technical Reports (79)

Lyophilization:

Responsible as a process expert for Lyophilization systems, regulatory guidance trends, evolving technology innovations, OEM supplier community partner, with contributions from early design through commissioning and startup activities of process and system lifecycle.

Prior experience supporting stand-alone and fill-line integrated lyophilizers with loading and unloading systems. Understanding of the technology behind vacuum, refrigeration, and condenser systems and the utilities that are required to supply these support systems. Ability to participate in system design discussions and workshops with client, design-build firms, and OEM. Ability to develop user requirement specifications, review equipment layouts and process flow diagrams, and work with OEM directly on design changes, procurement activities, and commissioning, startup, and handover. Collaborate with quality and CQV teams on equipment qualification, process validation, and regulatory readiness.

cGMP & Regulatory Compliance: Deep understanding of FDA (CFR)/EMA regulations (USP, Annex 1), FDA Guidance (Sterile Drug Products Produced by Aseptic Processing, Process Validation), ICH guidelines, ISO 13408, PDA Technical Reports (29, 64, and 90).

Biocontainment:

Responsible as a process expert for biocontainment processes in a BSL-3 minimum facility (high potency processes), regulatory guidance trends, evolving technology innovations, OEM supplier community partner, with contributions from early design through commissioning and startup activities of process and system lifecycle.

Prior experience with biocontainment systems such as nitrogen gas blanketing, biosafety cabinets, and isolators/RABS. Able to support clients with development of process flow diagrams, P&IDs, and zoning layouts. Understanding biosafety levels and exposure limits. Understanding of compliance around biocontainment systems. Support commissioning teams on testing strategies and execution.

Other Activities included in each role:

• Executes process system engineering from conceptual/planning to final/detail design phase on a wide range of projects from system enhancements or unit operation optimization through all-new greenfield construction.
• Works closely with Client personnel including Manufacturing, Facilities and Maintenance, Quality, and Validation to ensure systems are designed in accordance with current Good Manufacturing Practices.
• Understanding and development of process construction documents including piping & instrument diagrams (P&IDs), equipment general arrangement drawings, piping plans inclusive of orthographic and isometric drawings, operator access platform and equipment support drawings, line lists, tie-in lists, installation specifications, bills of material (BOM), scopes of work, etc.
• Interfaces with OEM’s/vendors as needed to accomplish equipment sizing and selection.
• Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team

Required Experience:

• Minimum of 7 years of pharmaceutical and biologics process system engineering/design experience.
• Expertise in aseptic filling (vials, syringes), visual inspection, biocontainment systems or lyophilization.
• Working knowledge of process definition means and methods including identifying process unit operations required.
• Experience with the previously listed regulatory standards and guidance.
• Excellent communication skills, written and oral, interpersonal skills and ability to interact with our valued team members and clients.
• Computer skills including AutoCAD (basic), Microsoft Office, and Microsoft Project (basic).
• Willing and able to travel as necessary for project requirements to include but not be limited to: project installation and start-up activities, client meetings, company sponsored meetings, trainings, industry related seminars, forums, or conventions, etc.
• BS degree in Chemical, Mechanical or Bio Engineering is preferred but consideration will be given to other engineering degrees based on actual project experience.

Travel:

This role may be based remotely anywhere in the United States; however, travel to customer locations is required approximately 30% to 50% of the time.

Our culture and commitment to our people is what sets us apart. We foster an environment of mutual respect, integrity, and unconditional interest in the individual and collective success of our professionals. Our model and entrepreneurial mindset offer a rewarding, challenging, and highly flexible path. As a Process Engineer, you will build a meaningful and fulfilling career with the support of professional development resources and mentorships including our First Year Experience program, Individual Development Plans, and Career Path resources and tools. You will be surrounded by exceptional talent who will support your development as both a world-class engineer and a highly effective leader.

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At Barry-Wehmiller we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work—therefore, people from all backgrounds are encouraged to apply to our positions. Please let us know if you require reasonable accommodations during the interview process. ​

Barry-Wehmiller is an equal opportunity employer. M/F/D/V This organization uses E-Verify.Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.

Company:

Design Group