Responsibilities
- Support a Safe working environment by aligning with all pertinent environmental health, safety & maintenance program practices, rules, and regulations.
- Provide technical leadership for Day-to-day operational shift support for Upstream and Downstream Drug Substance manufacturing.
- Experience in change control, nonconformance, corrective & preventative actions, and Commissioning & Qualification activities.
- Experience in various instrumentation with the following product platforms: Rockwell PLC Platform, Emerson DeltaV
- Day-to-day Operational Support: 24 x 7 Onsite/On Call: Rotational Support
- Troubleshooting support to Mfg.
- Lead FEED and detailed design for I&C scope; define I/O allocations, network topologies, and panel architectures aligned to process and facility constraints.
- Produce complete I&C design packages (enclosure details, panel layout/BOM, terminal block details, power distribution/grounding, I/O wiring, network integration details).
- Specify/oversee fabrication of control panels and field integration and manage vendor E&I scope.
- Configure, review and test DCS/PLC I/O layer and relevant applications; often DeltaV with ISA 88 batch (CM/EM classes, recipes, graphics), including SFAT/FAT.
- Troubleshoot instrumentation and control system issues, optimizing control strategies for safety, reliability and efficiency.
- Plan and execute SAT and support OQ/commissioning: loop checks, calibration coordination, punch-list closure, turnover documentation.
- Execute in a GxP manner with full traceability and change control (e.g., VCAT/audit trail), in alignment with CSV practices and 21 CFR Part 11 expectations.
- Being responsible for driving continuous improvement in partnership with Plant Engineering, Maintenance, Manufacturing, Process engineering and OPex to drive operational efficiencies.
- Responsible for collaborating within the AbbVie network to learn, implement and share Continuous improvement opportunities within the Drug Product manufacturing AbbVie Global network.
- Demonstrated understanding of project life cycles is preferred- Candidate should be familiar with engineering processes from initial conceptualization through project turnover to operations. Responsible for developing & maintaining Engineering Specifications, documents, drawings, and - Standard Operational Procedures (SOP) including Administrative SOPs and Job Aids.
- As a System SME, be accountable and responsible to provide the necessary support during the internal and external regulatory audits.
Requirements
- 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.
Nice to Have
- 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.
Additional Information
- 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.
