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

Overview
The Senior Manufacturing/Process Engineer IV manages and/or facilitates the design, installation, and commissioning of new equipment, facilities, utilities, computer systems, and laboratory equipment, modifications and upgrades, and troubleshooting for existing processes. Extensive knowledge of electromechanical and electronic controls (PLC’s), liquid packaging, process distillation, thermodynamics, materials handling, water system design and management, regulatory and quality control compliance. This role will ensure that commissioning and qualification activities are completed satisfactorily and in a timely manner and comply with all MOH requirements.

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 (SOP’s) 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.

Qualifications

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. A post-graduate education/degree is desired and may contribute towards the desired years of 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.

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 an equal opportunity employer and 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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Senior Process Engineer IV, Manufacturing