Quality Senior Engineer, CSV

The Senior Quality Engineer is responsible for carrying out Manufacturing Quality Assurance functions within the plant. The Senior Quality Engineer will provide Quality support for projects related to core production new software/computer systems new products/technologies/Automation systems. As part of the project team the Senior Quality Engineer will ensure all activities including Qualification/Validation Strategy Deviation Investigation and Resolution Risk Management activities etc. meet applicable Quality and Regulatory requirements.

Additionally the Senior Quality Engineer supports on-going production including by working with operations/quality teams for deviation resolution auditing of commissioning and validation documentation completed by others authoring and execution of newly identified qualification/validation protocols review and approval of critical planned maintenance routines and other quality assurance tasks assigned by the MQA Section Manager and/or the Plant QA Manager.

Responsibilities

• Responsible for implementing and maintaining the effectiveness of the Quality System.
• Support the ensure that all quality goals are met and all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility.
• Provide Quality support on project work related to core production as well as future process improvement projects new product/process launches Automation systems etc. while ensuring compliance with applicable regulations/standards. Lead project activities related to Quality and Compliance.
• Provide Quality support on computer system/software-based validations. Oversee data integrity initiatives to ensure security accuracy consistency and completeness of data throughout system usage.
• Support the Risk Management process throughout all quality system elements such as Design Control Product Surveillance Field Action etc. Update risk management file documents as needed.
• Ensures investigations of plant events are completed thoroughly and documented accurately and are included in the plant CAPA system. Performs product impact analyses for plant events and places product on QA hold where appropriate.
• Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments including remote off-shift support as required.
• Approves standard operating procedures; ensures procedures comply with policy and make sense.

Qualifications :

• Bachelors degree preferably in Biology Chemistry or Engineering
• 6 years of overall experience in Manufacturing Quality or Engineering
• Good verbal and written communication skills.
• Good problem solving and analytical skills
• Good interpersonal relations / communications skills
• Good negotiation skills
• Knowledge of quality / compliance management as well as regulations and standards affecting API Bulk Drug or Finished goods manufacturing.

Preferred

• Experience in manufacturing within pharmaceutical medical device biotechnology and food industry with cGMP is highly desirable
• Experience with implementing and maintaining the effectiveness of the Quality System. 
• Experience with Quality support on computer system/software-based/manufacturing automation validations and overseeing data integrity initiatives is highly desirable

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 ofthis posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic locationand 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 anybonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys soleand absolute discretion unless and until paid and may be modified at the Companys 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 and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

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Work :

No

Employment Type :

Full-time