Serán BioScience · 19 hours ago
Cleaning Validation Engineer III, Manufacturing Science and Technology
Bend, Oregon
Full-time
Onsite
Mid Level
3+ years expSerán BioScience develops and manufactures novel drug products for a variety of pharmaceutical applications, and they are seeking a Cleaning Validation Engineer III to oversee the equipment Cleaning Program. This role involves supporting equipment cleaning and verification of cleanliness while ensuring compliance with GMP standards and collaborating with cross-functional teams for optimizations.
Biotechnology
No H1B
Responsibilities
Oversees the clinical equipment Cleaning Program with minimal guidance, driving optimizations that facilitate a translation to commercial
Serves as a subject matter expert on cleaning, providing support around equipment cleaning and verification methods, allowable carryover limit calculations, and release procedures
Supports Cleaning Program activities, including lifecycle management, CAPAs, and equipment onboarding
Develops and manages protocols, workplans, and templates within the scope of the Cleaning Program
Leads cleaning-related projects, assessing impacts of individual changes and collaborating with impacted departments on implementation
Authors and contributes to technical reports and presentations
May supervise others and perform job functions within the capacity of a supervisor
Responsibilities may increase in scope to align with company initiatives
Performs other related duties as assigned
Qualification
Required
B.S. in Science or Engineering discipline with 3+ years of experience; or M.S. in Science or Engineering discipline, with 2+ years of experience
Knowledge of GMP compliance and quality systems; at least two years of GMP experience
Knowledge of regulatory expectations and industry practices related to cleaning
Strong project management skills with the ability to coordinate multi-departmental projects
Ability to think strategically and holistically
Excellent verbal and written communication skills
Excellent organizational skills and attention to detail
Excellent time management skills with a proven ability to meet deadlines
Ability to collaborate and work in cross-functional teams
Ability to function well in a high-paced and at times stressful environment
Ability to maintain productive relationships with coworkers, clients, and other contacts outside the company
Strong analytical and problem-solving skills
Ability to prioritize tasks and to delegate them when appropriate
Willingness to accept feedback from a variety of sources
Ability to constructively manage conflict
Prolonged periods of sitting or standing at a desk and working on a computer
Must be able to lift up to 15 pounds at a time regularly and up to 25 pounds occasionally
Adheres to consistent and predictable in-person attendance
Motor skills required for basic processing operations (assembling and disassembling equipment, pouring liquids, visual assessments, etc.)
Benefits
Generous PTO accrual
Low-cost health benefits
5% 401(k) contribution that does not require an employee match or vesting
Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period
Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions
Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage
An Employee Assistance Program provides support for all things related to our employees’ wellbeing
Access to pet insurance
Company
Serán BioScience
At Serán, Our mission is to provide optimized drug development and manufacturing services for our clients, from discovery to the clinic.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Dan Smithey, PhD
President, CEO and Founder
Company data provided by crunchbase