Integration Engineer

Pentangle Tech Services | P5 Group; Allendale (NJ); On-site; USD 85,000 - 110,000; Full time

Job summary

Pentangle Tech Services | P5 Group in New Jersey seeks an Integration Engineer, II to support engineering and development for new and existing products. The role involves prototyping, testing, documentation, and transferring processes to manufacturing.

You will develop validation plans, work across R&D, Quality, Manufacturing, and Regulatory teams, and help optimize processes while resolving CAPAs and process drifts.

Qualifications

• B.S. in Chemical, Mechanical, Industrial or Biomedical Engineering and 3–5 years in an engineering role.
• Ability to execute project deliverables to a schedule and work in cross-functional teams.
• Strong communication skills and ability to interact across R&D, Quality, Manufacturing and Regulatory.

Responsibilities

• Support new product launches from concept to launch completion, including prototyping and testing.
• Develop and execute Master Validation Plans and Protocols/Batch Records.
• Troubleshoot issues during prototyping, scale-up and manufacturing.
• Prepare Bills of Materials and collaborate to develop cost estimates.
• Write or revise batch records and SOPs for new products.
• Collaborate with cross-functional teams to move projects forward using data-driven decisions.
• Assist with scale-up and process optimization and CAPA investigations.

Skills

Problem-solving

Root cause investigations

CAPAs

Communication

Education

B.S. in Chemical Engineering, Mechanical Engineering, Industrial Engineering or Biomedical Engineering

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Minitab

SolidWorks

Microsoft Project

Job description

The Integration Engineer, II, will be responsible for supporting the engineering and development activities of new and existing products. The ideal candidate has a fundamental understanding of manufacturing processes and possesses a high degree of professionalism and maturity.

Essential Job Functions

• Support new product launches from initial concept to launch Completion, including activities for prototyping and testing, creation of technical documents and specifications, and transfer of processes to manufacturing.
• Support creation of detailed timelines for new product introductions and follow-through on project tasks through launch completion.
• Develop and execute Master Validation Plans and Validation Protocols/Batch Records for new/existing product lines
• Work independently or in support of other engineers/scientists in troubleshooting technical issues encountered during prototyping, scale up and manufacturing of products.
• Prepare Bills of Materials for new product lines and processes, working collaboratively with various groups (production, quality control, ERP) to develop cost of goods estimates.
• Write or revise batch records and standard operating procedures to support new product introductions
• Work closely with cross-functional teams and make data driven decisions to move projects forward that align with business goals.
• Perform other related duties and responsibilities as assigned or required, including scale-up and/or process optimization of existing products.
• Ensuring business continuity by providing support and prompt investigation and resolution of process performance drifts and CAPAs
• Assist with various special ad hoc projects and other duties as assigned.

Moved by Urgency

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing job duties, the employee is occasionally required to stand, walk, sit, use hands to handle or feel objects, tools, or controls, reach with hands and arms, climb stairs, and talk or hear. The employee must occasionally lift or move office products and supplies up to 50 pounds.

Supervisory Responsibilities

None

Education, Experience, and Certifications:

• B.S. in Chemical Engineering, Mechanical Engineering, Industrial Engineering or Biomedical Engineering plus 3-5 years of experience in an Engineering role
• Ability to execute project deliverables to a schedule.
• Ability to work within a team environment and build relationships outside of the department (R&D, Quality, Manufacturing, Regulatory, etc.)
• Ability to listen and clearly communicate verbally, in writing and in person to people at various levels of the organization.
• Experience with common problem-solving skills, including issue resolution, root cause investigations and CAPAs.
• Proficient in Microsoft Word, Excel, PowerPoint.
• Experience with Minitab, SolidWorks, and Microsoft Project is a plus