Senior Engineer, Validation

Regulatory Jobs; Cincinnati (OH); On-site; USD 110,000 - 170,000; Full time

Job summary

AbbVie seeks a Senior Validation Engineer to lead maintenance, validation, and engineering activities in the clinical packaging area. You will supervise equipment, facilities, utilities, and cleaning validation, coordinating with Operations, engineering services, and vendors to ensure product quality and regulatory compliance.

The role requires a BS in engineering, 5+ years of validation/engineering experience in pharma, and familiarity with validation documentation, VMS, and AbbVie standards.

Qualifications

• 5+ years combined experience in validation and/or engineering in the pharmaceutical sector.
• Experience creating and executing validation documents in VMS.
• Familiarity with AbbVie engineering standards and specifications.
• Understanding of pharmaceutical packaging equipment.

Responsibilities

• Manage all departmental capital projects and coordinate services with vendors.
• Lead equipment, facility, utility and cleaning validation activities.
• Maintain the Validation Master Plan (VMP) and change control docs.
• Identify cost-reduction, flexibility, and capacity-improvement opportunities.
• Interface with Operations and Quality through Validation Review Boards.
• Ensure validation documentation integrity through reviews.
• Investigate and resolve validation-related issues promptly.
• Lead quality improvement projects to ensure regulatory compliance.
• Represent department in internal and external audits.

Skills

Validation

Engineering

GxP

VMS

Education

Bachelor’s Degree in Engineering

Tools

VMS

Job description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

The Senior Validation Engineer functions as the lead for all maintenance, engineering, and validation activities within the clinical packaging area. Equipment, facility, utilities and cleaning are within the scope of responsibility. The incumbent will be the primary liaison with the Operations, engineering services, and third party vendors for executing activities within area of responsibility. The incumbent will also be responsible for the management of the area Engineering Technician. All responsibilities should be executed in a manner to ensure that product quality is maintained at the appropriate level to meet R&D and Corporate Quality Standards/Expectations.

Responsibilities

• Manage all departmental capital projects and miscellaneous engineering activities. Work with in-house functional support and outside vendors to coordinate required services.
• Manage all equipment, facility, utility and cleaning validation activities.
• Maintain the Validation Master Plan (VMP) as appropriate. Responsible for Validation Change Control documentation and managing the electronic tracking system.
• Identify and implement opportunities to reduce costs, increase flexibility, and generate additional capacity through process improvement initiatives.
  Interface with area managers from the Operations and Quality functions through the Validation Review Boards.
• Ensure the integrity, quality, adequacy, and appropriateness of validation documentation through comprehensive document review.
• Ensure thorough investigation and timely resolution of issues related to equipment, facilities, and utilities.
  Manage validation related, quality improvement projects to foster R&D compliance to regulatory, corporate and department requirements.
• Represent department in quality audits, both internal and external, in regards to validation and engineering compliance.
• Cultivate and foster strong working relationships with packaging operations and engineering validation disciplines.
• Initiate change requests (CR) for Standard Operating Procedures (SOP) in support of equipment and operations processes.
• Supervise FTE engineering technicians and contract validation engineering as needed. Ensure employee resource allotment and workload requirements are balanced to meet the forecasted needs of the business.
• Partners with all levels of key business functions to ensure packaging equipment has the functionality and is equipped to support new and ongoing clinical studies. Responsible for ensuring equipment reliability expectations are achieved in a high-throughput, clinical packaging facility.
• Continually evaluates and balances short term production support needs with long term strategic objectives of the department.

#LI-JW1

• Bachelor’s Degree, a BS in an engineering discipline.
• 5+ years combined work experience in validation and/or engineering positions within the pharmaceutical area.
• Knowledge/experience in creating and executing validation documents in VMS.
• Knowledge/experience in Abbvie engineering and financial systems.
• General understanding of Abbvie Engineering Standards and Specifications.
• General understanding of pharmaceutical packaging equipment

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company'ssoleandabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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