Validation Specialist I

AbbVie-posted 2 days ago

Full-time • Mid Level

Worcester, MA

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Purpose Describe the primary goals, objectives or functions or outputs of this position. The primary responsibility for the Validation Specialist I 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

Responsible for participating in implementation and maintenance of the effectiveness of the Quality System to meet all applicable regulatory requirements
Ensures that all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility
Executes 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
Ensures investigations of validation failures are completed thoroughly and documented accurately and are included in the plant CAPA system where required by policy
Participates 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
May supervise contract validation resources in the timely completion of activities in his/her area of responsibility
May lead, author, or review investigations and implementation of preventive and corrective action

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

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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