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 Twitter, Facebook, Instagram, YouTube and LinkedIn.

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 and be a part of our mission to transform the manufacturing process!

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.

Significant Work Activities -Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Qualifications

• A minimum of a Bachelor’s degree in Engineering, science or related technical discipline with 7+ years industry experience in Medical Device, Biotech or Pharmaceutical industries.

• Solid time management, organization, and follow-through skills with the ability to work on and manage multiple tasks and projects with tight deadlines. Ability to exercise professional discretion and judgement.

• Experience with new product, equipment, and/or technology development in the medical device or pharmaceutical industry, including proven skills in specification development, design, fabrication, qualification, and troubleshooting.

• Established use of statistical methods in experimental design, data analysis, development of robust manufacturing processes, and/or validations.

• Experience with Quality System Regulations (QSR) and Design Control, and understands AATB, ISO, and/or FDA guidelines as related to Human Tissue.

• Processing and Medical Device Manufacture.

• Demonstrated ability to analyze issues and develop and deploy solutions within a dynamic environment.

• Established strong verbal, written, and interpersonal communication skills with an ability to interface at all levels of the business environments.

• Demonstrated ability to present to senior management, defend strategy, timing, resource needs, risks, and plan, and obtain approval on key decisions such as release of funds and phase gate advancement.

• Experience with Microsoft Applications including Word, Excel, PowerPoint, Outlook, Project and Visio.

• Experience with AutoCad and SolidWorks.

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.​

• 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 committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.