Manufacturing Process Engineer IV - Branchburg Twp, United States - AbbVie

Description

Job Description

Looking for a challenging role in Manufacturing/Process Engineering? Our team is seeking a highly skilled Manufacturing/Process Engineer IV who can apply their extensive technical and scientific knowledge, leadership, engineering principles, statistical techniques, and validation expertise to drive innovation in new product and technology introductions.

In this role, you will be responsible for project management, problem-solving, and serving as a subject matter expert across various disciplines.

With minimal supervision, you'll have the opportunity to showcase your ingenuity and complete challenging assignments.

This position is based at our Branchburg Manufacturing site, which specializes in AlloDerm and Strattice. If you're passionate about contributing to cutting-edge products, join our team and make a significant impact. Apply today

Responsibilities

Provide Operations Engineering leadership and support for process requirements and specifications in manufacturing processes, including design transfer, process validation, product line extensions, and continuous improvement activities in a cross-functional environment.

Conduct effective root cause analysis to investigate issues relating to products and processes, providing leadership and support throughout the process.

Develop strategies and designs for complex validations, including novel equipment and processes.

Lead or participate in project teams for new product introductions, technology transfers, and product support activities to ensure successful transfers, presenting to all levels of the organization and external third parties.

Write SOPs, validation protocols, qualifications protocols, and batch records for complex validations, executing validation/qualification protocols, coordinating first builds, and training manufacturing staff.

Review and guide lower-level professionals' work in this area.

Ensure compliance with applicable policies and procedures, contributing to specific programs and projects with a significant impact on schedules, programs, and resource allocations.

Identify stakeholders, scope of work, and resource requirements to complete project lifecycles and ensure quality and effectiveness of key results.

Utilize advanced statistical techniques and analysis to report and translate findings to others, reviewing and advising statistical analysis to lower-level professionals.

Challenge experimental designs, engineering principles, process excellence principles, problem-solving principles, and design for manufacturability related to process changes, technology, and/or new product transfers.

Take responsibility as Process and Equipment SME during Regulatory Agency Audits, preparing documentation packages and presenting information in front of regulatory agents.

Remain current on company business drivers, proactively recommending changes to systems and investigating and identifying opportunities for improvement.

This position is based at our Branchburg Manufacturing site, which specializes in AlloDerm and Strattice.

This position requires 20% travel to various locations.