Engineer Validation
Engineer Validation
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Purpose
The QA Validation Analyst/Engineer is responsible for planning and overall approval of validation tasks. Responsibilities may also include executing validation activities. Under the direction of the Validation Section Manager this individual will participate in the implementation of the Validation quality program at the plant under minimal supervision. Level of responsibility and performance is commensurate with grade level.The Validation Engineer responsibilities may include: the review of commissioning and validation
documentation completed by others leading authoring or reviewing investigations and implementation of preventive and corrective action review and authoring of plant standard operating procedures review
and approval of critical planned maintenance routines setup of laboratory samples for qualification
participation in the establishment of plant quality systems supporting regulatory and third party audits.
Responsibilities
- 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.
Qualifications :
Qualifications
- Bachelors degree preferably in Biology Chemistry or Engineering
- Prefer 2 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
- Prefer knowledge of quality / compliance management as well as regulations and standards affecting API Bulk Drug or Finished goods manufacturing.
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 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 shortterm 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 any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and 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 serving our community and embracing diversity and inclusion. It is AbbVies 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 ;
US & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
