OSD Validation Lead - CQV & Tech Transfer

Serán BioScience; Emeryville (CA); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Over four weeks of paid time off annually

Employer contributions to retirement account after 90 days

Health plans with minimal employee contributions

Employee Assistance Program

Access to pet insurance

Job summary

Serán BioScience is seeking a Senior Validation Engineer to support the development of a new manufacturing facility in Emeryville, California. This role involves leading commissioning and qualification of manufacturing processes, ensuring compliance with cGMP and regulatory standards, and collaborating with teams to define project specifications and timelines.

Candidates should have a Bachelor’s degree and at least 8 years of experience in validation and engineering within a non-sterile pharmaceutical context. A robust benefits package is offered, including paid time off and health plans.

Qualifications

• Minimum of 8 years of quality, validation, or engineering experience in non-sterile pharmaceutical manufacturing.
• Proficiency in enterprise systems and ability to learn new software.
• Experience in FAT/SAT of process equipment is preferred.

Responsibilities

• Leads the commissioning and qualification of equipment for OSD manufacturing.
• Supports technology transfer and operations in OSD processes.
• Manages installation activities and collaborates with cross-functional teams.

Skills

Knowledge of cGMPs guidelines

Multiple project management

Effective communication

Leadership skills

Problem-solving

Education

Bachelor's degree in a relevant technical field

Tools

Microsoft Office

Job description

Serán BioScience is seeking a Senior Validation Engineer to support the development of a new manufacturing facility in Emeryville, California. This role involves leading commissioning and qualification of manufacturing processes, ensuring compliance with cGMP and regulatory standards, and collaborating with teams to define project specifications and timelines.

Candidates should have a Bachelor’s degree and at least 8 years of experience in validation and engineering within a non-sterile pharmaceutical context. A robust benefits package is offered, including paid time off and health plans.