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Senior Quality Assurance Specialist
2 weeks ago
We are seeking a skilled Validation Engineer to join our team at our Westport facility. The role of the Validation Engineer is crucial in ensuring customer satisfaction by delivering high-quality validation services.
- The Validation Engineer will oversee and coordinate site validation projects under prospective, concurrent, and retrospective validation studies.
- The successful candidate will be responsible for actively working on validation projects, being the departmental point person, and completing all associated project documentation.
- Participating in risk assessment and design review processes for all business units;
- Tracking and generating weekly metrics (QMS, EHS, Compliance Wire);
- Facilitating PQR review, regulatory review, and laboratory equipment review processes;
- Staying up-to-date with current and changing regulatory guidance for relevant areas of validation; and
- Supporting internal EHS requirements, procedures, and policies.
Required Skills and Qualifications
- Bachelor's degree in a science-based or engineering discipline;
- Experience in the Pharmaceutical industry;
- Excellent project management skills;
- Proficiency in Microsoft Office suite of programs.
Benefits
The ideal candidate will have a strong understanding of validation principles and practices, excellent communication and interpersonal skills, and the ability to work independently and collaboratively as part of a team.
The selected candidate will have opportunities to grow professionally and personally, and contribute to the success of our organization.
