What are the responsibilities and job description for the Lead Engineer, Quality Validation position at Katalyst CRO?
Job Description
The contract Lead Engineer, Quality Validation will be responsible for providing quality and technical support for qualification and validation activities related to laboratory instruments, temperature control units and LFH/BSC units for internal customers. The individual will support and facilitate the review and approval of qualification/validation documentation for all stages of the equipment life cycle qualification process.
Responsibilities
The contract Lead Engineer, Quality Validation will be responsible for providing quality and technical support for qualification and validation activities related to laboratory instruments, temperature control units and LFH/BSC units for internal customers. The individual will support and facilitate the review and approval of qualification/validation documentation for all stages of the equipment life cycle qualification process.
Responsibilities
- Provide quality oversight of Blue Mountain application for induction, calibration and maintenance of all lab equipment and instrumentation.
- Collaborate with lab systems owners on the induction and/or qualification activities of lab assets.
- Adhere to regulatory guidance, policies, and procedures for qualification, and validation of Lab equipment and instrumentation.
- Use risk management principles for qualification and remediation efforts.
- Provide regular updates directly to Management.
- Perform other related duties as assigned.
- 8-12 years of relevant experience and bachelor's degree in science or related field. Biopharmaceutical or Pharmaceutical experience preferred.
- Direct experience in qualification and validation using FDA, EMEA and ICH guidance required.
- Experience with qualifications of lab equipment and validation of processes associated to manufacture of clinical and commercial products highly desirable.
- Must have in-depth understanding and application of GMP and validation principles, concepts, practices and standards in the US and internationally.
- Knowledge of biologics/gene therapy processes desirable.
- Prior QA experience highly desirable.
- Able to execute complex concepts, techniques, and standards and new applications based on quality principles and theories.
- Able to implement solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness.
- Demonstrates knowledge of industry best practices and trends.
- Excellent verbal, written, and interpersonal communication skills are required.
