Process Engineer III

Abbvie; Jersey (AR); On-site; USD 90,000 - 130,000; Full time

Job summary

AbbVie is seeking a Senior Process Engineer to provide technical support across cross-functional teams, oversee process validation and equipment qualification, and drive manufacturing improvements from concept through project closure. The role emphasizes GMP compliance and collaboration with development and operations on new products.

The ideal candidate has a strong engineering background, 5+ years of experience, and expertise in data analysis, SPC, and qualification protocols.

Qualifications

• Bachelor's degree in Engineering, Science or closely related discipline; 5+ years of significant engineering/operational experience.
• Has demonstrated competency within a discipline and strong technical knowledge.
• Interacts well with diverse groups within engineering and maintains relationships with internal and external collaborators.
• Excellent written and verbal communication; capable of presentations.
• Experience in medical devices, pharmaceutical, biologics or similar industries.
• Experience with financial systems and fiscal control.

Responsibilities

• Lead process engineering activities in the product line, including validation and equipment qualification (IQ/OQ/PQ).
• Troubleshoot production issues using data analysis and SPC tools to reduce losses and improve yield.
• Support Engineering Change Orders and supplier changes with updated specs and training.
• Design and develop equipment/fixtures for manufacturing, including in-house or vendor solutions.
• Assist in integrating new products into manufacturing and advise on materials, processes, and cost aspects.
• Validate new and revised manufacturing processes and ensure compliance with company standards.
• Design and execute engineering studies to test hypotheses and drive project outcomes.

Skills

Process engineering

Validation

Equipment qualification IQ/OQ/PQ

Data analysis

SPC and statistics

Cross-functional collaboration

Problem solving

Education

Bachelor's degree in Engineering/Science or related field

5+ years engineering/operational experience

Post-graduate degree desired

Tools

Data acquisition systems

Statistical tools (SPC)

Process capability analysis

Job description

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 atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

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 projects from concept through project closure within or across disciplines.

Responsibilities:

• Lead process engineering activities in product line, including Process Validation, Cleaning Validation, Equipment Qualification (IQ/OQ/PQ), investigations to address root cause.
• 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. May supervise other engineers or technicians.

Qualifications

• Bachelors Degree in Engineering, Science, or closely related discipline is desired, or equivalent technical experience plus demonstrated competence, with a desired 5+ years of significant engineering and/or operational experience. A post-graduate education/degree is desired, and may contribute towards the desired years of experience.
• Has demonstrated competency within a discipline.
• Possesses a strong technical knowledge and application of concepts, practices, and procedures. Works on problems of complex scope where analysis of situations or data involves multiple competing factors. Demonstrates judgment within defined procedures and practices to determine appropriate action.
• Interacts well with diverse groups within engineering and maintains strong working relationships with internal and external collaborators.
• Listens to and understands others\' points of view and articulates tactfully and respectfully one\'s own perspective orally, in writing, and in presentations.
• Works well with other engineers in a collaborative, fast-paced goal-driven environment.
• Possesses interpersonal skills to negotiate and reconcile differences.
• Has a technical background in medical devices, pharmaceutical, biologics, or similar industries
• Has demonstrated competency with financial systems and in fiscal control.

Preferred:

• Bachelors Degree in Engineering, Science, or closely related discipline is Highly Desired
• 5+ years' experienceof Process Engineering within operations in a GMP regulated environment, in Cleaning Validation and Equipment Qualification (IQ/OQ/PQ) are Highly Desired.

Additional Information

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,andwemay ultimately pay more or less than the posted range. This range may bemodified in thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipate in our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or anyother form ofcompensation and benefitsthat are allocable to a particular employeeremains in the Company'ssoleandabsolutediscretion unless and until paid andmay bemodified at the Company’s sole and absolute discretion, consistent withapplicable 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:

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