Manufacturing Engineer
Job in
Allendale, Bergen County, New Jersey, 07401, USA
Listed on 2026-06-01
Listing for:
Actalent
Full Time
position Listed on 2026-06-01
Job specializations:
-
Engineering
Manufacturing Engineer, Process Engineer, Quality Engineering
Job Description & How to Apply Below
Job Title:
Manufacturing / Integration Engineer IIJob Description
The Manufacturing / Integration Engineer II supports the engineering and development activities of new and existing products, with a strong focus on manufacturing processes, process validation, and design for manufacturability. This role works across the full product lifecycle, from initial concept and prototyping through scale-up, validation, and transfer to full manufacturing, while collaborating closely with cross-functional teams and external customers.
Responsibilities
+ Support new product launches from initial concept through completion, including prototyping, testing, and transfer of processes to manufacturing.
+ Develop and maintain detailed project timelines for new product introductions and ensure project tasks are completed through launch.
+ Create and execute Master Validation Plans and Validation Protocols/Batch Records for new and existing products.
+ Independently troubleshoot and resolve technical issues encountered during prototyping, scale-up, and manufacturing activities.
+ Prepare Bills of Materials for new product lines and processes, collaborating with production, quality control, and ERP teams to develop cost of goods estimates.
+ Write, revise, and maintain batch records and standard operating procedures to support new product introductions and process changes.
+ Work closely with cross-functional teams such as R&D, Quality, Manufacturing, and Regulatory to make data-driven decisions that align projects with business goals.
+ Drive scale-up and process optimization initiatives for existing products to improve performance, robustness, and efficiency.
+ Ensure business continuity by providing prompt investigation and resolution of process performance drifts and supporting CAPA activities.
+ Apply structured problem-solving methods, including root cause investigations, to address process and product issues.
+ Support and, when appropriate, lead various special projects and ad hoc assignments related to process development, validation, and improvement.
+ Engage with customers in a professional and collaborative manner to understand requirements, communicate technical information, and support successful product integration.
Essential Skills
+ B.S. degree in Chemical Engineering, Mechanical Engineering, Industrial Engineering, or Biomedical Engineering.
+ 3-5 years of experience in an engineering role, preferably in development, manufacturing engineering, or process engineering.
+ Hands-on experience with process validation, including developing and executing validation protocols and batch records.
+ Experience in process development and process optimization, with the ability to translate pilot or lab-scale processes into robust, manufacturable processes.
+ Fundamental understanding of manufacturing processes and manufacturing process improvement.
+ Strong communication skills, including the ability to clearly convey technical information verbally, in writing, and in person to stakeholders at various levels.
+ Demonstrated ability to execute project deliverables according to schedule and manage multiple tasks in a dynamic environment.
+ Proven ability to work effectively within a team environment and build productive relationships with cross-functional partners such as R&D, Quality, Manufacturing, and Regulatory.
+
Experience with structured problem-solving, including issue resolution, root cause investigations, and CAPA activities.
+ Proficiency in Microsoft Word, Excel, and PowerPoint.
+ Customer-facing communication skills and professionalism suitable for representing engineering and manufacturing capabilities to external stakeholders.
Additional
Skills & Qualifications
+ Experience in the medical device or similar regulated manufacturing environment.
+ Background in development, manufacturing engineering, process improvement, and process engineering.
+ Familiarity with process engineering tools and methodologies for scale-up and process optimization.
+
Experience with Minitab or other statistical analysis software.
+
Experience with Solid Works or similar CAD tools.
+
Experience with Microsoft Project or other project management software.
+ Ability to make data-driven decisions and present findings and recommendations to cross-functional teams.
+ High degree of professionalism, maturity, and ownership over assigned projects and responsibilities.
+ Comfort working in a fast-paced environment with a constant level of activity and diverse project work.
Work Environment
You will work on-site as part of a growing engineering team of approximately 9-10 engineers, collaborating closely with an Associate Integration Engineer while also working independently on assigned projects. The role follows a standard daytime schedule of approximately 8:30 a.m. to 5:00 p.m. You may need to travel to New York City 1-2 times per week during the first two months to support integration and collaboration activities.
The environment offers a steady flow of diverse projects,…
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