Serán BioScience is motivated to find an industry-experienced Validation Engineer to support the development of a new commercial manufacturing facility. The Senior Validation Engineer will be part of a cross functional team that will plan and execute commissioning/qualification (CQ) projects for equipment and critical utilities process, tech transfer of manufacturing process from clinical to commercial site, and subsequent validation for process, cleaning, and computerized systems to support commercial distribution of non-sterile pharmaceutical products. Experience will determine title and salary, with preference given to applicants with over 8 years of experience with Oral Solid Dosage and an interest in leading teams. Those with less experience are encouraged to apply.
As a critical member of the Commercial Steering Committee, the Senior Validation Engineer will be responsible for planning and execution of CQ and validation projects. In order to perform this task, applicants require a thorough understanding of the manufacturing processes and systems as well as an understanding of all applicable regulations, guidelines, policies, procedures, and requirements. Successful candidates will understand that the development and execution of CQ and validation projects requires communication with internal and external cross functional teams. Demonstrated ability with effective communication is essential for identifying required information, alignment of strategies, and mitigation risks while maintaining good working relationships.
Duties and Responsibilities
Leads the commissioning and qualification (C&Q) of new and existing equipment and systems for OSD manufacturing, facilities, and utilities, ensuring compliance with cGMP, FDA, and EU regulatory standardsSupports the clinical technology transfer and operations in design, scale-up, optimization, and troubleshooting of OSD processes and equipmentDevelops and executes protocols for equipment IQ/OQ/PQ in alignment with site validation master plans and project timelinesCollaborates with cross-functional teams to define equipment specifications, user requirements (URS), and establish project timelines and budgetsManages installation activities, equipment FAT/SAT execution, and vendor coordination to ensure technical and compliance requirements are metCollaborates with multidisciplinary team to complete change controls, deviations investigations, and CAPAs as requiredSupports regulatory inspections and client auditsPerforms other related duties as assignedResponsibilities may increase in scope to align with company initiatives
Required Skills and Abilities
Demonstrates knowledge of cGMPs guidelines and regulations acquired through education, experience, and trainingPreference for those who posses knowledge of Global Regulatory requirements (E.g., FDA / MHRA / EMEA)Showcases foundational understanding of the compliance and technical requirements for the application of various scientific concepts used in developing different dosage forms of pharmaceutical products (primarily oral solid dose, while experience with sterile products is desired)Experience with regulatory expectations and industry practices for CQ and Validation using Product Lifecycle approachExperience with designing CQV plans for Facilities, Utilities, and Process equipment desiredAbility to manage multiple projects, create and work within internal timeliness, solve problems, deliver on commitments, and utilize interpersonal skills in a cross-functional teamStrong time-management skills and the ability to organize and coordinate multiple projects at onceCommunicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside the CompanyAbility to prioritize tasks and to keep leadership apprised of performance timelinesAccepts feedback from a variety of sources and constructively manages conflictDemonstrates leadership skills with ability to motivate and coach cross functional teamsExperience in FAT/SAT of process equipment, and knowledge operating principles of typical OSD process equipment preferred.Proficiency in enterprise systems, Microsoft Office, and other office productivity tools, with aptitude to learn new software and systems
Education and Experience
Bachelor's degree in relevant technical field Requires a minimum of 8 years of quality, validation, or engineering experience in non-sterile clinical and commercial pharmaceutical manufacturingFundamental understanding of process equipment, utilities, manufacturing process, cleaning process and Quality systems used in the pharmaceutical/biotech industry8 years of GMP compliance experience, including knowledge of 21 CFR Part 11 requirements, GAMP 5, among others
Physical Requirements
Prolonged periods of sitting or standing at a desk and working on a computerProlonged periods of sitting or standing in a manufacturing environmentMust be able to lift fifteen pounds at timesAdheres to consistent and predictable in-person attendance
Level and compensation will be based on experience.
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.
