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.)
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.
