Senior Process Engineer IV, Manufacturing

AbbVie - Waco, TX

Full-time - Senior

Waco, TX

Chemical Manufacturing

About the position

The Senior Process Engineer IV at AbbVie is responsible for managing and facilitating the design, installation, and commissioning of new manufacturing equipment and processes. This role requires extensive knowledge in various engineering disciplines, including electromechanical controls, liquid packaging, and regulatory compliance. The engineer will ensure that all commissioning and qualification activities meet regulatory requirements and are completed in a timely manner, contributing to the overall efficiency and effectiveness of manufacturing operations.

Responsibilities

• Develop project objectives by reviewing project proposals and plans; conferring with management.
• Determine project schedule by studying project plan and specifications; calculating time requirements; sequencing project elements.
• Maintain project schedule by monitoring project progress; coordinating activities; resolving problems.
• Determine project specifications by studying product design, customer requirements, and performance standards; completing technical studies; preparing cost estimates.
• Confirm product performance by designing and conducting tests.
• Control project plan by reviewing design, specifications, and plan and schedule changes; recommending actions.
• Control project costs by approving expenditures; administering contractor contracts.
• Prepare project status reports by collecting, analyzing, and summarizing information and trends; recommending actions.
• Lead process and equipment troubleshooting to support deviations, corrective actions and related issues.
• Develop and implement standard operating procedures (SOPs) or automation improvement changes.
• Participate in design and hazard reviews of plant expansions or process changes and serving as the technical point of contact for contractor services including design, fabrication, installation and validation.
• Initiate and manage projects, tracking spending of budgets, creating scope of work, justification, risk assessments, cost estimates, implementing purchase order requisitions, and controlling payment schedules.
• Conduct employee training (cGMP / OSHA/etc.) and maintain records.
• Provide training for plant personnel including the design and format of commissioning and qualification protocols and the documentation of results to ensure that protocols are properly documented in accordance with cGMP's.
• Oversee the commissioning and qualification process by writing, reviewing, executing, and/or approving protocols to ensure that the process is consistent, meets MOH guidelines, complies with cGMP's and meets all company policies and procedures.
• Provide technical expertise in the design and implementation of commissioning and qualification protocols to ensure that validations comply with MOH guidelines and cGMP's.
• Maintain and improve the validation system through establishment or changes to Standard Operating Procedures.
• Support the Change Control process for all validated systems.
• Work to build a team environment with all departments.
• Perform other duties as assigned.

Requirements

• Bachelor's degree in Engineering, Science, or closely related discipline is desired, or equivalent technical experience plus demonstrated competence, with a desired 6+ years of significant engineering and/or operational experience.
• Ten (10) years of experience in the field. Prior manufacturing or process development engineering experience is preferred.
• Five (5) years of project management experience leading projects.
• Five (5) years of relevant experience with an emphasis in Commissioning and Qualification.
• Proficiency in MS Office (Word, Excel, PowerPoint) and other computer-based applications.
• Knowledge of FDA regulated industrial environment, preferred.
• Demonstrated ability to manage projects to completion on time and within budget.
• Experience in the manufacturing of pharmaceutical or medical devices with knowledge of the validation water systems, clean rooms, aseptic processing operations, packaging, sterilization, laboratory equipment, and computer systems validation.
• Demonstrated leadership skills to perform as a member of cross-functional work teams.
• Ability to work and interact with peers, vendors, various personnel in scientific, engineering, QA, Validation, and operational disciplines.
• Knowledgeable in Lean Six Sigma Methodologies.
• Detail-oriented and self-motivated.
• Able to work in a controlled environment that includes surgical mask and goggles.

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k) plan
• Short-term incentive programs