Senior Engineer, Validation Commissioning - 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 – 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. 

An engineering professional that works with project owners, subject designers/engineers and other project team members to plan, and complete tasks associated with commissioning, qualification and validation of new and modified equipment, facilities, utilities, product, processes etc.in line with project, operations and quality objectives. Level of responsibility and performance is commensurate with grade level. The main objective is to establish evaluation, testing and documentation for risk management, commissioning and validation applying product and regulatory requirements and risk management to result in robust, high quality products. This includes optimizing systems that support the work in and around this area of responsibility.

Responsibilities:

• Support Global Commissioning, Qualification, and Validation (CQV) management and strategy development.
• Support Global Paperless CQV initiatives including but not limited to managing licenses, training, change requests, template development, and developing work instructions.
• Lead cross functional global teams to identify and implement continuous CQV improvement opportunities and cost reductions into policy, procedures, and good practices.
• Develop into Subject Matter Expert in Abbvie’s Paperless CQV initiative and Risk Based Approach to CQV.
• Providie Commissioning, Qualification, Validation (CQV) support to global projects through the entire project life cycle including scope management, scheduling, budgeting and coordinating activities with cross functional team and with contractors.
• Strategize CQV execution with project teams including  RACIs, scopes and project resourcing.
• Support vertical integration of multidiscipline departmental initiatives including integration of Technical SME knowledge base, Engineering Standards and standardized CQV execution.
• Departmental KPI development and management.
• Departmental Document Control .
• Prepare and deliver periodic status reports to all internal project stakeholders (internal customers, engineering and plant management, etc.).
• Lead the continues improvement and implementation of change control for C&Q and Engineering documents. Generate technical justification determining impact of change on documents that support Global Assurance Engineering documents.
• Technical Support for C&Q Kneat Program roll out, sites change control and continues improvement.
• Project management of smaller team, short duration projects within larger projects. Responsibility may include project coordination, monitoring, reporting, meeting management, and team communication.
• Participate in industry groups/ forums for sharing extraction of good industry practices.
• Support departmental FAT, SAT, and IV/OV executions

• Bachelor’s Degree or higher in Engineering, science, or closely related discipline is desired, or equivalent technical experience plus demonstrated competence, with a desired 3+ years of significant engineering and/or operational experience.
• Experience in the development of commissioning, qualification, validation using Risk Based Verification methodologies  deliverables including specifications and testing protocols that can stand up to regulatory scrutiny.
• 6+ years of overall experience in Manufacturing, Quality or Engineering including 4 major validation subjects (e.g. Computer, Equipment, Cleaning, Process, etc.) preferred
• A technical background in health care,  laboratory diagnostics, medical devices, biologics/ pharmaceutical, or similar industries (preferred).
• Strong interpersonal, communication, and negotiation skills with demonstrated ability to work within a team environment.
• Knowledge of quality / compliance management as well as regulations and standards affecting Biologics, Aseptic, API, Bulk Drug or Finished goods manufacturing preferred
• Ability to supervise contract team members (prior supervisory experience preferred)
• Ability to manage complex projects and multiple projects (5+) simultaneously

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

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• 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. ​

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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