Cleaning Validation & Commissioning Specialist (Pharmaceutical Manufacturing)
Cleaning Validation & Commissioning Specialist (Pharmaceutical Manufacturing)
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1 Vacancy
Job Description
An engineering professional that works with project owners subject designers/engineers and other project team members to plan and complete tasks associated with commissioning qualification and validation of new and modified equipment facilities utilities product processes line with project operations and quality objectives. Level of responsibility and performance is commensurate with grade level. The main objective is to establish evaluation testing and documentation for risk management commissioning and validation applying product and regulatory requirements and risk management to result in robust high quality products. This includes optimizing systems that support the work in and around this area of responsibility.
Responsibilities
- Work with enduser and project engineer to develop User Requirements Specifications and Functional / Design Specifications for new or modified equipment facilities and utilities.
- Support Factory Acceptance Testing in conjunction with Project Engineer to confirm unit is acceptable.
- Identify risk controls critical elements and traceability of equipment design based on FMEA or other risk assessment.
- Develop and execute commissioning qualification and validation test protocols to ensure that the unit functions according to specifications.
- Perform minor troubleshooting of issues encountered during commissioning and documentation of unresolved issues.
- Able to support broader aspects of projects at times including: project leadership developing operational procedures support training of maintenance/technical staff/operators on new equipment reviewing new or modified product documentation to ensure compatibility with qualified equipment and implementing changes in equipment parameters or recipes.
- Leads Execution of Risk Management. including periodic review and update per the Validation Master Plan interface with best practices establishing teams work practices including overall program. Understands risk management principles. Can find and review documentation. Understands controls impact of change trace controls and can estimate ratings using appropriate scale. Timely. Demonstrated success in FMEA authorization/facilitation.
- Qualification as QRM facilitator commensurate with responsibility.
- May supervise contract validation resources in the timely completion of activities in his/her area of responsibility
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Qualifications :
- Bachelors Degree in Engineering science or closely related discipline is desired or equivalent technical experience plus demonstrated competence with a desired 3 years of significant engineering and/or operational experience.
- Experience in the development of commissioning qualification validation and risk management deliverables including specifications and testing protocols that can stand up to regulatory scrutiny. Pharmaceutical experience strongly preferred.
- 6 years of overall experience in Manufacturing Quality or Engineering including 4 major validation subjects (e.g. Computer Equipment Cleaning Process etc.) preferred
- A technical background in health care nutritional products laboratory diagnostics medical devices pharmaceutical or similar industries (preferred).
- Strong interpersonal communication and negotiation skills with demonstrated ability to work within a team environment.
- Knowledge of quality / compliance management as well as regulations and standards affecting API Bulk Drug or Finished goods manufacturing preferred
- Ability to supervise junior or contract team members (prior supervisory experience preferred)
- Ability to manage complex projects and multiple projects (5) simultaneously
- Open to considering nonlocal candidates willing to relocate to North Chicago IL; must have Pharmaceutical experience
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 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 :
Fulltime
Employment Type
Full-time
