Responsibilities:

• Manage packaging development activities from concept through launch while maintaining project

objectives, timelines, and costs.

• Evaluate and develop new materials and/or alternate packaging materials, packaging solutions or

packaging systems, based on patient, user, and technical requirement for Pharma, Eyecare,

combination product and medical device

• Partner with device development team to ensure system level requirements for combination

products and medical device packaging are developed, verified, and validated in accordance with

design controls.

• Partner with Extractables/Leachables and Toxicology functional teams to obtain safety assessments

for packaging materials.

Maintain familiarity to evolving regulatory and compendia changes and translate pharmaceutical and

packaging industry trends to business opportunities.

• Lead packaging validation activities by ensuring regulatory compliance with 21CFR, part 201, 210,

211.

• Provide technical expertise: in the development of component specifications for packaging systems

and to the manufacturing teams assisting with the resolution of problems associated with

packaging/component equipment.

• Support the authoring and technical review of regulatory submission documentations along with

providing responses to submission questions related to packaging.

• Responsible for compliance with applicable policies and procedures. Ensures quality and

effectiveness of key results of major projects within function through sound design, early risk

assessments, and implementation of fallback strategies. Has full awareness of the potential

consequences (defects and failure modes) of design changes to established processes. Mitigates risk

within functions through sound design, early risk assessments and implementation of fallback

strategies.

• Identifies, plans, and conducts medium- to large-size projects within engineering specialty requiring

custom, risk-managed execution plans, investigations, and/or equipment. Manages multiple, often

concurrent, projects and meets deadlines.

• Applies technology in innovative ways. Combines technologies to anticipate or address customer

needs; shares solutions across sites; employs proven solutions to increase effectiveness of

engineering methodology or manufacturing process. Mentors others by sharing technical expertise

and providing feedback and guidance.

• Interacts with both senior management and external personnel on significant technical matters

often requiring coordination between organizations. Submits articles for internal or external

publication. Acts as a trusted advisor. Balances bottom line objectives of a project with long-term

interest of customer. Is identified as a Subject Matter Expert in the discipline. Participates in internal

teams to develop and align procedures and standards. May influence validation strategy.

• A Bachelors Degree in Engineering, science, or closely related discipline is desired, or equivalent technical experience plus demonstrated competence, with a desired 8+ 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.
• Has a career history marked by a consistent series of technical contributions and accomplishments. Significant contribution to product or process development or improvement through creative application of technical effort will equally be recognized.
• 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. Exercises judgment and advises management as to the appropriate actions.
• 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 health care, medical devices, pharmaceutical, biologics, or similar industries (preferred).
• Has demonstrated competency with financial systems and in fiscal control.

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.