AbbVie
Job Opportunity At 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. The primary responsibility for the Validation Specialist is the planning and overall approval of validation tasks. Under the direction of the Validation Section Manager, will participate in the implementation of the Validation quality program, but s/he will be expected to independently manage 5+ key projects simultaneously. May be expected to coach/supervise contractors and/or junior Validation Specialists. Responsibilities include: Participating in implementation and maintenance of the effectiveness of the Quality System to meet all applicable regulatory requirements Ensuring that all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility Executing tasks as required to implement the Validation Master Plan and maintain in a validated state the equipment, utilities, facilities, automated process controllers, information systems, cleaning processes, manufacturing processes, laboratory instruments and analytical methods to demonstrate that product will perform consistently as intended Ensuring investigations of validation failures are completed thoroughly and documented accurately and are included in the plant CAPA system where required by policy Participating with plant and external engineering resources on new installations/systems to ensure that factory/site/commissioning documentation is in accordance with cGMP and supports validation Supervising contract validation resources in the timely completion of activities in his/her area of responsibility Leading, authoring, or reviewing investigations and implementation of preventive and corrective action Qualifications include: Bachelor's Degree Required (preferably in Biology, Chemistry or Engineering) 6+ years of overall experience in Manufacturing, Quality or Engineering including 4 major validation subjects (e.g. Computer, Equipment, Cleaning, Process, etc.) preferred Strong verbal and written communication skills Solid problem solving and analytical skills Solid interpersonal skills, including ability to negotiate/influence without authority Ability to supervise junior or contract team members (prior supervisory experience preferred) Ability to manage complex projects and multiple projects (5+) simultaneously Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing preferred Key Stakeholders include various stakeholders within the site including but not limited to Plant Operations, Quality, Engineering/Maintenance, and Science & Technology. Compensation: $82,500 - $157,500 We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. 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.
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. The primary responsibility for the Validation Specialist is the planning and overall approval of validation tasks. Under the direction of the Validation Section Manager, will participate in the implementation of the Validation quality program, but s/he will be expected to independently manage 5+ key projects simultaneously. May be expected to coach/supervise contractors and/or junior Validation Specialists. Responsibilities include: Participating in implementation and maintenance of the effectiveness of the Quality System to meet all applicable regulatory requirements Ensuring that all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility Executing tasks as required to implement the Validation Master Plan and maintain in a validated state the equipment, utilities, facilities, automated process controllers, information systems, cleaning processes, manufacturing processes, laboratory instruments and analytical methods to demonstrate that product will perform consistently as intended Ensuring investigations of validation failures are completed thoroughly and documented accurately and are included in the plant CAPA system where required by policy Participating with plant and external engineering resources on new installations/systems to ensure that factory/site/commissioning documentation is in accordance with cGMP and supports validation Supervising contract validation resources in the timely completion of activities in his/her area of responsibility Leading, authoring, or reviewing investigations and implementation of preventive and corrective action Qualifications include: Bachelor's Degree Required (preferably in Biology, Chemistry or Engineering) 6+ years of overall experience in Manufacturing, Quality or Engineering including 4 major validation subjects (e.g. Computer, Equipment, Cleaning, Process, etc.) preferred Strong verbal and written communication skills Solid problem solving and analytical skills Solid interpersonal skills, including ability to negotiate/influence without authority Ability to supervise junior or contract team members (prior supervisory experience preferred) Ability to manage complex projects and multiple projects (5+) simultaneously Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing preferred Key Stakeholders include various stakeholders within the site including but not limited to Plant Operations, Quality, Engineering/Maintenance, and Science & Technology. Compensation: $82,500 - $157,500 We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. 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.