Process Engineer II (IQ,OQ,PQ)

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

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.

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. 

Qualifications

• 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.

Preferred:

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

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this roleat  the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on manyfactors  including  geographic location, and we may ultimately  pay more or less than the posted range. This range may be  modified in the future. ​

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

• This job is eligible to  participate in our short-term incentive programs. ​

Note: No amount of pay is  considered to be wages or compensation until such amount isearned,  vested,  and determinable. The amount and availability of  any bonus, commission, incentive, benefits, or any other form of compensation and benefits that areallocable to a   particular employee  remains in the Company's sole and absolute discretion unless and until paid and may be  modified at the Company’s sole and absolutediscretion,  consistent with applicable law. ​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html