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Principal Quality Engineer 3140 Rochester, NY Perm/Full $75,000 - $90,000

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Principal Quality Engineer
Provide QA validation leadership across Global Operations in establishing direction (validation policies, standards, guidelines) and training program which results in reproducible, documented processes that consistently meet defined specifications and comply with all internal and external validation requirements. Support major validation projects with trained, competent validation leader resources.

Job Duties:
Develop and maintain GMP validation documents (e.g., policies, standards, guidelines, templates and examples) that are the basis of a good quality system.

Provide leadership in developing the Global Validation Manual.

Develop and provide training on validation and related subjects.

Maintain communication links among the Global Operations validation contacts.

Gather regulatory and industry intelligence in validation trends and best practices.

Assess GMP compliance of existing systems against current validation standards.

Assist plants on items related to validation for external GMP inspections.

Provide QA validation leader services on major validation projects.
Qualifications Education: Bachelors or Masters degree in Chemistry, Engineering, or related science.

Experience: 5 years pharmaceutical industry experience: Process, equipment, utility, facility, and computer validation; QA/QC at a manufacturing plant.
3 years experience in management.
Desirable to have project management experience, technical support at a manufacturing plant, and experience with global operations.

Special Skills: Proved communication, leadership and technical skills.

Specialized Training: Desirable to be multi-lingual.