About the role

Aplyr's Quick Take

This role is for a Senior Validation Engineer focused on commissioning and qualification projects in a new manufacturing facility for non-sterile pharmaceuticals. You'll be part of a team responsible for ensuring processes and systems meet regulatory standards, requiring both technical expertise and strong communication skills.

Good fit

Ideal candidates have over 8 years of experience in validation, particularly with Oral Solid Dosage, and are comfortable leading projects and teams. A collaborative working style and ability to navigate cross-functional communication are essential.

Worth noting

The position emphasizes both technical knowledge and leadership potential, which may appeal to those looking to step into a more senior role. The company is open to less experienced applicants, which could indicate a supportive environment for growth.

Serán BioScience is motivated to find an industry-experienced Validation Engineer to support the development of a new commercial manufacturing facility. The Senior Validation Engineer will be part of a cross functional team that will plan and execute commissioning/qualification (CQ) projects for equipment and critical utilities process, tech transfer of manufacturing process from clinical to commercial site, and subsequent validation for process, cleaning, and computerized systems to support commercial distribution of non-sterile pharmaceutical products. Experience will determine title and salary, with preference given to applicants with over 8 years of experience with Oral Solid Dosage and an interest in leading teams. Those with less experience are encouraged to apply.

As a critical member of the Commercial Steering Committee, the Senior Validation Engineer will be responsible for planning and execution of CQ and validation projects. In order to perform this task, applicants require a thorough understanding of the manufacturing processes and systems as well as an understanding of all applicable regulations, guidelines, policies, procedures, and requirements. Successful candidates will understand that the development and execution of CQ and validation projects requires communication with internal and external cross functional teams. Demonstrated ability with effective communication is essential for identifying required information, alignment of strategies, and mitigation risks while maintaining good working relationships.

Skills & Tags

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Aplyr's read

Serán BioScience is a dynamic biotechnology firm innovating in diagnostics and therapeutics, attracting a diverse workforce from scientists to business developers.
Synthesized from recent postings & public sources

What's promising

•Strong focus on developing cutting-edge diagnostics and therapeutics.
•Recent hiring across diverse roles indicates growth and expansion.
•Opportunities for career advancement in a specialized biotech field.

What to watch

•Biotechnology sector can be volatile and subject to regulatory changes.
•Limited public information about financial stability and long-term viability.
•Highly specialized roles may limit opportunities for generalists.

Why Serán BioScience

•Specializes in both diagnostics and therapeutics, offering a broad scope of innovation.
•Recent expansion into commercial manufacturing suggests strategic growth.
•Emphasis on quality assurance highlights commitment to regulatory compliance.

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About Serán BioScience

Serán BioScience

seranbio.com

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Serán BioScience is a biotechnology company focused on developing innovative solutions for healthcare, particularly in the areas of diagnostics and therapeutics.