AbbVie

Salary Min: 94000

Salary Max: 178500

Company Description

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

The Process Engineer IV is responsible for providing engineering production support including:

• Identifying and driving process and technology improvements to maximize process performance.
• Ensuring business continuity by providing regular on-the-floor manufacturing support and prompt investigation and resolution of process performance drifts, CAPAs, and NCRs
• Collecting, monitoring, analyzing, troubleshooting, and reporting manufacturing data related to performance in the areas of quality, cost, and speed/service to market.
• The Senior Engineer II will develop subject matter expertise in all key manufacturing processes, through process changes, production improvement activities and new product transfers
• Responsible for the initiation and follow-through of the change control processes.

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., 40%

Provide technical evaluations and support for Engineering Change Orders and Supplier Changes including updates to specifications, drawings and procedures and required operator training., 30%

Continuous Improvement Projects – Identify opportunities, propose projects, gain approval for resources and lead initiatives using Lean and Six-sigma methodologies.,15%

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 purchased from vendors. Design, build and qualify fixtures, machines, or equipment to facilitate manufacturing capability of products., 10%

Occasional travel required to support continuous improvement initiatives, including external porcine suppliers., 5%

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Qualifications

The requirements described in this section are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Education and Experience

• Experience in a regulated environment. Preferred experience in a cGMP environment.
• Bachelor’s Degree in a technical field with 6+ years of experience; OR Master’s Degree in a technical field with 5+ years of experience. Prefer engineering degree from an accredited institution.

Essential Skills, Experience, and Competencies (includes Licenses, Credentials)

• Experience with MS Office applications including Word, Excel & Outlook.
• Demonstrated understanding and use of statistical methods in experiment design and data analysis.
• Able to work independently and proactively in conjunction with all levels of the organization.
• Experience with Quality System Regulations (QSR) and working in a medical device regulatory environment, generating manufacturing process documentation, FMEA and Risk Assessments, Design Control, Human Tissue Regulations, and Sterilization Validation Standards.
• Six Sigma, Value Stream Mapping, Lean Manufacturing, Design for Manufacturability, DOE.
• Biological Products and aseptic processes.
• Development of robust manufacturing processes, validation, and process monitoring.
• Experience with root cause analysis methods.
• Experience with applications including Minitab or other statistical software, Microsoft PowerPoint, Project, & Visio.

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 role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. Salary: $94,000 - $178,500
• 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 is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable 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 absolute discretion, 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