Quality Validation Engineer

This position is not in System Validation, we are looking for candidates with experience in Equipment Validation.

Locals Only. No relocation.

Summary:

As the Quality Engineering Leader directed, the Quality Engineer II is accountable for the production of the equipment and support in process validation or verification studies. Successful performance requires close work with quality management, operations, suppliers, and BD associates to assure compliance with all BD quality policies, procedures, and practices. Must demonstrate a working understanding of the ISO 13485 Quality Systems Regulations on Class I/II/II products. Preferred core experience in Quality Assurance, Quality Control, Validation (IQ, OQ,PQ), and Nonconformance management for regulated devices(i.e.: Good Manufacturing Practices, ISO, FDA). Proven ability to develop solutions to a variety of problems of moderate scope and complexity, using policies and procedures for guidance.

Job Responsibilities:

1. Experience performing equipment and process validation studies such as writing and/or reviewing protocol, report, data analysis, and deviations for new, existing, and site relocation activities.

2. Have a working knowledge of medical device or biological equipment maintenance from a Quality standpoint such as Preventive Maintenance, Calibration, and out-of-tolerance activity support to the site and equipment owners.

3. Author and execute installation, operational, and performance qualifications for analytical and manufacturing equipment.

4. Execute validation and qualification of GMP equipment and functions throughout the manufacturing facility.

5. Review and update FMEA or Risk documents as needed for validation activity for the site

6. Perform additional duties to ensure business continuity during the relocation of the manufacturing processes into a new area. Duties include but are not limited to execution of QA inspection to support dual operations, and review and approval of documents such as batch records to support finished product release.

Education and Experience:

BS Biological Sciences, Chemistry, Bio-tech engineering, Bio-engineering, or related field.

Minimum of 3-5 years of experience for QE II and 5-7 years for Sr. QE in Medical Device, Biotech or Pharma Industry.

Ability to write technical documents. Knowledge of quality system methodologies

Statistical Analysis basic knowledge e.g Minitab or Excel

Strong knowledge of Process Validation and equipment validation

Strong understanding and knowledge of ISO 9001, ISO 14971, and/or ISO 13485 (Design Control, Supplier Management, and Risk Management)

Hands-on experience using Six Sigma methodology

SAP knowledge

Equipment management systems such as BMRAM knowledge preferred