Director, Engineering, Technical Expert Sterile Fill

The Director Engineering Technical Expert Sterile Fill provides enterprise-level technical leadership for sterile fill engineering across AbbVie's strategic investment portfolio, with accountability for biologics sterile filling, Annex 1-aligned contamination control, aseptic processing design, barrier technology strategy, equipment / facility interfaces, GMP readiness, validation / CQV integration and technical assurance within Strategic Investments - Engineering. The role shapes and governs engineering strategies for strategic investments by setting technical direction, aligning standards and assuring robust execution across priority capital programs, technology platforms and future manufacturing capabilities.

Responsibilities

Establish, maintain and deploy global engineering standards, technical practices and governance expectations for biologics sterile fill engineering; Provide governance and escalation for technical decisions with material safety, quality, compliance, cost, schedule, operability or lifecycle impact; Provide senior engineering leadership for strategic capital investments, including new facility builds, technology platform deployments, capacity projects and future capability investments; Provide senior technical leadership for sterile filling of biologics and parenteral products; Ensure facility, equipment and process design decisions are aligned with EU GMP Annex 1 expectations; Govern technical strategy for isolators, restricted access barrier systems, Grade A critical zones, Grade B / C / D background environments, unidirectional airflow, glove systems, transfer systems and aseptic interventions; Lead engineering input to contamination control strategy development; Lead technical decision-making for biologics sterile fill engineering, aseptic processing design, barrier technology selection, equipment / facility interfaces, GMP readiness, validation / CQV integration and technical assurance; Coordinate technical input from project teams, site SMEs, external engineering partners, vendors and cross-functional stakeholders; Share engineering best practices, lessons learned and technical knowledge across sites, regions and projects; Build capability through coaching, mentoring and technical review discipline

Requirements

Bachelor's degree in Engineering, Science or a relevant technical discipline; 12+ to 15+ years of relevant engineering, manufacturing, capital project, technical operations or regulated manufacturing experience; Demonstrated technical capability in biologics sterile filling, aseptic processing, Annex 1 contamination control expectations, isolators / RABS, cleanroom interfaces, sterile filtration, environmental monitoring, GMP readiness, validation / CQV integration and technical assurance; Demonstrated ability to operate across global functions, strategic investment teams, manufacturing sites, project teams, suppliers, vendors and external engineering partners; Strong communication, risk management, technical judgment, stakeholder engagement and structured problem-solving skills

Nice to have

Advanced degree; Experience supporting pharmaceutical, biopharmaceutical, medical device, API, peptides, biologics, sterile or similarly regulated manufacturing environments

Benefits

Comprehensive benefits package including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) for eligible employees; Eligible to participate in long-term incentive programs