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 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.
