Job Description
Job Description
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:
- 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.
Requirements:
- 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.