Cleaning Validation Engineer III, Manufacturing Science and Technology
Bend, Oregon, United States · On-site
Mid level$200M raised
The Cleaning Validation Engineer III oversees the equipment Cleaning Program, supporting equipment cleaning and verification of cleanliness while ensuring compliance with GMP standards. Near-term work is focused on clini…
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Associate Director of Quality Assurance, Operations
Bend, Oregon, United States · On-site
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Quality Control Scientist I/II, Environmental Monitoring/Microbiology
Bend, Oregon, United States · On-site
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Laboratory Instrumentation and Validation Specialist
Bend, Oregon, United States · On-site
Senior$200M raised
Serán is seeking a Laboratory Instrumentation and Validation Specialist . This person will be Responsible for onboarding, maintaining, troubleshooting, repairing, and validating laboratory instruments and associated comp…
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Full-time
bachelor degree, postgraduate degree
Paid time off, Health benefits, 401(k) contribution, Life insurance, Long-term disability insurance, Employee assistance program
Posted 46d ago
~40 hrs/week
Responsibilities
The Cleaning Validation Engineer III oversees the clinical equipment cleaning program and serves as a subject matter expert for cleaning and verification methods. They lead cleaning-related projects, manage protocols, and collaborate with cross-functional teams to ensure compliance with GMP standards.
Requirements
Candidates must hold a B.S. or M.S. in a science or engineering discipline with at least 2-3 years of relevant experience. Strong knowledge of GMP compliance, regulatory expectations, and project management skills are required.
Full job description
The Cleaning Validation Engineer III oversees the equipment Cleaning Program, supporting equipment cleaning and verification of cleanliness while ensuring compliance with GMP standards. Near-term work is focused on clinical manufacturing, but the engineer positions the program for future success in the commercial manufacturing facility. The engineer is responsible for key tasks within the Cleaning Program and collaborates with cross-functional teams to implement cleaning-related optimizations.
Serán BioScience develops and manufactures novel drug products for a variety of pharmaceutical applications. We aim to build a workforce that is collaborative, creative, and kind. In addition to the skills required of the role, qualified candidates will approach their work with integrity and enthusiasm to promote a positive work culture. Employees are awarded generous PTO accrual, low-cost health benefits, and a 5% 401(k) contribution that does not require an employee match or vesting. Want to learn more about what we do, who we are, and how you can contribute? We look forward to seeing your application.
\nDuties and 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
Required Skills and Abilities
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
Education and Experience
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
Physical Requirements
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.)
Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
Benefits Summary:
Serán employees accrue over four weeks of paid time off annually. 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, along with access to pet insurance.
At Serán, Our mission is to provide optimized drug development and manufacturing services for our clients, from discovery to the clinic. Our science-driven approach utilizes predictive design tools, novel chemistry, analytical tools, enabling delivery technologies, and a thorough knowledge of quality and regulatory requirements to guide our customers on their clinical development path.
Serán’s team are experts in delivery of poorly soluble compounds. Serán employs a range of novel technologies and pharmaceutical manufacturing operations to overcome drug development challenges for both small and large molecules, including complex granulations, spray-dried dispersions, hot melt extrudates, IR and MR tablet technologies, multiparticulates, and engineered particles for inhalation.
Our custom-built spray driers enable a wide variety of particle formation, from nano-structures to micro-particulates. Our particle engineering approaches are combined with our broad expertise in solid dosage forms resulting in the optimum clinical trial materials for your drug, including suspensions, capsules, and tablets.
Offices: 63040 Lower Meadow Dr, Suite 110, Bend, Oregon 97701, US
How many Manufacturing jobs are open in Bend, OR right now?
There are currently 120 open manufacturing positions in Bend, OR listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Manufacturing roles in Bend, OR?
Companies currently hiring include Lonza, Serán BioScience, Kendall Auto Group, Wonderful Pistachios & Almonds, Puget Collision, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Manufacturing jobs in Bend, OR?
Yes — 2 of the 120 open manufacturing positions offer remote or hybrid work (0 remote, 2 hybrid).
How do I apply for Manufacturing jobs in Bend, OR?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.