Validation Specialist I
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Job Location:
Worcester, MA - USA
Monthly Salary:
Not Disclosed
Posted on:
4 hours ago
Vacancies:
1 Vacancy
Job Summary
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
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
- May lead author or review investigations and implementation of preventive and corrective action
Qualifications :
- Bachelors 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
Various stakeholders within the site including but not limited to Plant Operations Quality Engineering/Maintenance and Science & Technology
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 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 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 and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
