Validation Specialist with Biopharma Expertise
3 weeks ago
We are seeking a highly skilled Validation Specialist to join our team at DD Enterprises. This is an exciting opportunity for a motivated individual to contribute to the growth and success of our organization.
Key ResponsibilitiesThe successful candidate will be responsible for:
- Leading validation efforts for biopharma equipment and processes, ensuring compliance with regulatory requirements;
- Developing and executing validation protocols, procedures, and reports;
- Collaborating with cross-functional teams to identify and mitigate risks;
- Maintaining accurate records and documentation of validation activities;
- Providing training and support to colleagues on validation best practices;
To be considered for this role, you must have:
- A minimum of 8-10 years of experience in validation and quality assurance within the biopharma industry;
- Demonstrated expertise in regulatory standards, including GMP, FDA regulations, and ISO standards;
- Proficiency in risk management principles and techniques;
- Excellent communication and interpersonal skills, with the ability to work effectively with diverse stakeholders;
The ideal candidate will possess:
- Strong knowledge of validation methodologies and documentation;
- Familiarity with ASME BPE Code and its stipulations for dead leg and slope;
- Hands-on experience with calibrating field instruments for biopharma processes;
- Ability to prepare and execute qualification documents;
We offer a competitive salary range of $120,000 - $180,000 per annum, commensurate with experience, as well as a comprehensive benefits package, including health insurance, retirement savings plan, and paid time off.
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