Validation Engineer (Cleaning Validation)

Sern BioScienceBend, OR, US

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Validation Engineer (Cleaning Validation)

Sern BioScience is seeking a Validation Engineer to support the cleaning verification and validation program for clinical phase testing of novel pharmaceutical drug products.

The Validation Engineer will be responsible for developing and executing commissioning and qualification protocols for equipment and systems and performing validation studies for process, cleaning, computerized systems, and critical utilities needed to support clinical and commercial distribution of non-sterile Oral Solid Dosage pharmaceutical products. Initial focus will be to evolve and manage a cleaning verification and validation program for clinical drug product production.

Duties and Responsibilities

Evolve and manage cleaning verification / validation program for clinical supply manufacturing facility
Leads and supports projects for new product introduction, tech transfer, product / process optimization in a clinical manufacturing facility for oral solid dose products
Authors and executes commissioning, qualification, and validation protocols and reports
Defines and coordinates execution of cleaning development studies for manufacturing equipment
Facilitates and drafts risk assessments with interdisciplinary teams related to equipment design, operation, and cleaning processes
Leads continuous improvement initiatives related to manual and automated cleaning processes
Defines and tracks metrics to assess cleaning program effectiveness and efficiency
Leads and supports investigations related to process equipment operations and cleaning processes
Supports capital projects and implementation of new technologies
Responsibilities may increase in scope to align with company initiatives
Performs other related duties as assigned

Required Skills and Abilities

Knowledge of FDA cGMP guidelines and regulations acquired through education, experience, and training; additional knowledge of global regulatory requirements highly desirable (E.g., MHRA / EMEA)

Understanding of the Compliance and Technical requirements on the application of various scientific concepts used for developing different dosage forms of pharmaceutical products (primarily oral solid dose)

Familiarity with water systems, CIP, Part Washers, and OSD process equipment

Hands on experience with execution of cleaning verification studies and sampling methods (swab, rinse, visual, etc.)

Proven experience with cleaning validation, protocol development, execution, troubleshooting, and summary reports

Effective written, oral, and interpersonal communication skills

Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside the Company

Accepts feedback from a variety of sources and constructively manages conflict

Strong time-management skills and the ability to organize and coordinate multiple projects at once

Proficiency in enterprise systems, Microsoft Office, and other office productivity tools, with aptitude to learn new software and systems

Education and Experience

Bachelor's degree in engineering or related technical field

A minimum of 3 years of experience with pharmaceutical manufacturing, engineering, validation, or other relevant experience in cGMP environment

Physical Requirements

Prolonged periods of sitting at a desk and working on a computer

Prolonged periods of sitting or standing in a manufacturing environment

Must be able to lift fifteen pounds at times

Adheres to consistent and predictable in-person attendance

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Validation Engineer • Bend, OR, US