Equipment Process Engineer II

AbbVie•Branchburg Township, NJ

21h

About The Position

The primary job function of this position is to provide technical support to cross-functional teams working with little or no supervision, apply project management knowledge, engineering and product/process knowledge, and ingenuity to complete medium size projects from concept through project closure within or across disciplines.

Requirements

Bachelor’s Degree in engineering or scientific discipline.
Demonstrated technical knowledge and ability to solve related issues and provide effective solutions that support overall engineering/operational objectives.
Ability to balance priorities and/or resources to ensure immediate demands are achieved without sacrificing long-term operational strategies.
Ability to write policies, procedures, and communications to regulators and management.
Ability to conduct effective training as necessary for the operation of facilities/equipment.
Uses standard office program m(Microsoft) for daily communications and project work.

Nice To Haves

3 years’ experience of Process Engineering in Pharmaceutical or Medical Device industry is Highly Desirable.
Prior operations experience in a GMP regulated environment Highly Desirable.
Experience with equipment/parts specification, qualification (PQ) Desirable.

Responsibilities

Support and monitor Production as required to troubleshoot material, process and equipment problems including product loss and inefficiencies. Utilize technical abilities and experience, including the use of structured analytical techniques and technical tools such as data acquisition (manual and computerized), data analysis – especially including process capability analysis, SPC and other statistical tools.
Provide technical evaluations and support for Engineering Change Orders and Supplier Changes including updates to specifications, drawings and procedures and required operator training.
Design and develop equipment and processes for use in the manufacturing of products. This may include in-house design, or the use of products or components as purchased from vendors. Design, build and qualify fixtures, machines, or equipment to facilitate manufacturing capability of products.
Support integration of new products into the manufacturing operation. Provide input to Development and Operations on materials, processing, the manufacture, and cost aspects of new products.
Assist in the validation of new and revised manufacturing processes and equipment, ensuring compliance with all applicable company standards, procedures, and all other applicable specifications.
Design and execute engineering studies to test hypothesis related to project outcomes.
Applies scientific and technical knowledge to projects and responsible for timely project execution.
Lead process engineering activities in support of the product line, including: Process Validation, Cleaning Validation, Equipment Qualification, investigations to address root cause