Cleaning Validation Engineer III, Manufacturing Science and Technology

Open 20d

Summary

Oversees and optimizes equipment cleaning programs for a biopharma manufacturer, ensuring GMP compliance and supporting clinical-to-commercial transitions.

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.

Duties 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 Skill and Ability

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.)

Visit to learn more about company culture and the community of Bend, Oregon.

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.

The Corporate Headquarters of Serán BioScience are located at 63047 Layton Ave, Bend, OR 97701

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What this application asks

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Resume/CV, Full name, Email, Phone, Current location, Current company

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Without providing dates of enrollment, can you confirm that you have completed the necessary education requirements of the position? yes / no · optional
Are you able to perform the essential functions of this job without reasonable accommodations? Note: We comply with the ADA and consider reasonable accommodation measures that may be necessary for qualified applicants/employees to perform essential job functions. choose one
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I certify that all statements made in connection with this application (whether contained herein (and/or any supplements) or made by me or others at my request during the course of the employment process) are true and complete in al respects. I acknowledge and agree that any incorrect, incomplete, false, fraudulent, or misleading statements made by me, either verbally or in writing, and/or any omission, concealment, or failure or answer any question fully, completely, and accurately, whether made by me or others at my request, will result in rejection of this application, denial of employment, or termination from employment if discovered after employment. choose one
I authorize the investigation of all matters which Serán deems relevant to my qualifications for employment, including, without limitation, work records, reference checks, education, and an investigation into my driving record. I authorize and request that all my present and former employers, references, educational institutions, and any others to furnish and release information about me, my employment record, and/or education, including a statement of reason for the termination of my employment and information regarding my work performance, disciplinary reports or actions, abilities, degrees obtained, transcripts, licenses and certifications, and other qualities and information Serán deems pertinent to my qualifications for employment. I release Serán (and all providers of information) from all claims and/or liabilities arising out of or in any way connected with Serán's background investigation. If employed, I release Serán from any claims and/or liabilites for future references it may provide regarding my work history and performance with Serán. choose one
I understand that if offered employment, I will be required to submit proof of my identity and legal right to work in the United States as a condition of employment. choose one
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I understand that any job offer may be contingent on me successfully passing a pre-employment drug screen. I agree to hold harmless and release Serán and its agents from all claims and/or liabilities resulting in whole or part out of the collection of specimens, testing and the appropriate use of the information from such testing. choose one
I understand that, if employed, my employment relationship with Serán will be at-will. Therefore, subject to applicable law, my employment may be terminated (and I may voluntarily resign) at any time, for any reason or no reason, with or without cause or prior notice. Nothing contained in this application, or provided in connection herewith, will be construed as an offer or promise of employment, nor does this application create any employment contract or guarantee that employment or any benefit will be provided or continued for any period of time. choose one
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