Lead Engineer Quality Validation
Lead Engineer Quality Validation
Posted on :
28-03-2025
Employer Active
1 Vacancy
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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:
- 812 years of relevant experience and bachelors 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 indepth 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.
Employment Type
Full Time
Key Skills
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