Validation Engineer - New Jersey, Piscataway

The announced job offer is made public by the firm: GenScript and it was included in jobs list the date of: 2022-10-22 in the website greenenergyjobsonline.com.

It is announced that they have a job offer at the category of Engineering and the jobs location is in the state of New Jersey at the city Piscataway, in the country US - at this current ZipCode: 08854

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Job Scope:

The Validation Engineer position reports to the Director of Facility Engineering - GenScript ProBio, USA, and is responsible for the validation activities of equipment and systems for the new cGMP Manufacturing site in East Hannover, NJ. This position is responsible for developing, preparing and executing user requirements and validation protocols for biotech manufacturing equipment and facility utility systems for the new GMP manufacturing site in East Hanover. This position will work closely with internal and external stakeholders in developing the site validation strategy and relevant standard operating procedures. This is a great opportunity to develop and manage the validation function within a CDMO business, to support the manufacturing operations that deliver products to client projects that transform the lives of patients.

Key Responsibilities:

1. Prepare, review and execute Validation protocols for biotech manufacturing equipment and support utility systems.
2. Analyzes validation test data to determine whether systems have met validation criteria or to identify root causes of production problems.
3. Develops Validation Master Plan, process flow diagrams, and Standard Operating Procedures.
4. Develops Computer System Validation procedures using GAMP 5 principles and in compliance with 21 CFR Part 11.
5. Prepare, review and execute temperature mapping protocols for GMP manufacturing and storage areas.
6. Conducts training of employees on validation protocols and standard operating procedures.
7. Coordinates the scheduling and testing of validation protocols with user departments and personnel.
8. Creates, populates, or maintains Master Equipment List database for tracking validation activities and validated systems.
9. Performs periodic reviews of validated equipment to ensure equipment/systems are complaint with current practices.
10. Prepares detailed summary reports based on results of validation test results.
11. Performs deviation investigations aimed to prevent deviation re-occurrence, including determining the root cause, identifying CAPAs, identifying product impact assessment, etc.
12. Conducts internal audits of validation processes to ensure compliance with internal or regulatory requirements.

Qualifications

1. Bachelor's degree in Pharmaceutical Engineering, Mechanical Engineering, or equivalent.
2. 5+ years of validation experience in a biotech/pharmaceutical cGMP production environment.
3. Experience working with GAMP 5 and 21 CFR Part 11 compliance.
4. Temperature mapping experience for GMP manufacturing and storage areas.
5. Understand essentials and requirements of quality management systems (QMS) used in GMP productions.
6. Ability to collaborate with all internal and external function groups, and adapt the priority and timeline change.
7. Strong interpersonal, verbal, and written communication skills.