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Senior Validation Engineer

Serán BioScienceBend, Oregon
On-site Full-time

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Experience Level

Senior

Qualifications

Minimum of 8 years of experience in validation engineering, preferably in Oral Solid Dosage manufacturing. Proven track record of leading teams and managing complex CQ and validation projects. Strong knowledge of applicable regulations and guidelines. Excellent communication skills to effectively collaborate with cross-functional teams.

About the job

Join Serán BioScience as a Senior Validation Engineer and contribute to the establishment of a cutting-edge commercial manufacturing facility. This pivotal role involves collaborating with a dynamic cross-functional team to spearhead commissioning and qualification (CQ) projects for equipment and critical utilities, facilitate tech transfers from clinical to commercial manufacturing, and oversee validation processes for production, cleaning, and computerized systems for non-sterile pharmaceutical products.
 
The ideal candidate will possess extensive experience, ideally exceeding 8 years, in Oral Solid Dosage forms, coupled with a passion for team leadership. However, we encourage applicants with a range of experiences to apply. As a key member of the Commercial Steering Committee, you will take charge of planning and executing CQ and validation initiatives. A comprehensive understanding of manufacturing processes, applicable regulations, and effective communication strategies is essential for success in this role. You will play a crucial role in liaising with both internal and external teams to align strategies, mitigate risks, and foster strong working relationships.

About Serán BioScience

At Serán BioScience, we are dedicated to advancing pharmaceutical manufacturing through innovative solutions and a commitment to quality. Our new commercial manufacturing facility represents our vision for the future, and we seek talented professionals to join us on this exciting journey.

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