Validation Engineer I Jobs

Overview
The primary responsibility for the Sr. Validation Engineer is the planning and overall approval of validation tasks. Under the direction of the Validation Manager, they will participate in the implementation of the Validation quality program and be expected to independently manage 5+ projects simultaneously. May be expected to coach/supervise contractors and/or junior Validation Specialists.

Responsibilities

• Responsible for the execution of sterilization qualifications and re-qualifications of process equipment, including autoclaves and fermenters.
• Responsible for execution of cleaning validations, temperature mapping of process equipment and shipping studies.
• 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.
• May lead, author, or review investigations and implementation of preventive and corrective action.
• May supervise contract validation resources in the timely completion of activities in his/her area of responsibility.
• Ensures investigations of validation failures are completed thoroughly and documented accurately and are included in the plant CAPA system where required by policy.
• Responsible for participating in implementation and maintenance of the effectiveness of the Quality System to meet all applicable regulatory requirements.
• 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.
• Ensures that all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility.

Qualifications

• 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.
• 3-6+ years of overall experience in Manufacturing, Quality or Engineering including 4 major validation subjects (e.g. Computer, Equipment, Cleaning, Process, etc.) preferred.
• Bachelor's Degree Required (preferably in Biology, Chemistry or Engineering).
• Strong verbal and written communication skills.
• Solid problem solving and analytical skills.
• Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing preferred.

• This job is eligible to participate in our short-term incentive programs.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• 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.

AbbVie is an equal opportunity employer including disability/vets. 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.