The Sr.
Engineer, Validation ensures cGMP regulatory compliance through adherence to site and corporate validation Plans, Policies, and Procedures.
This position supports ensuring accountability and oversight within the validation program, validation projects, and leads innovation.
Sr Engineer, Validation will independently work on multi-faceted projects (Capital, Client and Overhead), manage multiple tasks/priorities.
Core competencies for this position are Collaborates, Communicates Effectively, Directs Work, Ensures Accountability and Customer Focus.
This position provides Subject Matter Expertise (SME) and oversight in multiple disciplines owned by the validation department.
These disciplines are; Commissioning and Qualification, Computer Systems Validation, Validation Maintenance/Risk Management, and Laboratory Systems Validation.
The Sr.
Engineer, Validation performs with a high degree of autonomy and represents the department on interdisciplinary teams.
This position leads by example, achieves solutions to complex problems, serves as a technical expert, communicates effectively, collaborates and bridges GAPs.
The Sr.
Engineer, Validation supports engineering, quality, manufacturing sciences and technology, and manufacturing by providing SME support and accountability within the Validation department.
The Sr.
Engineer, Validation will also be responsible for providing leadership and technical guidance to the team aimed at implementing best practices and improving the overall performance of the team.
Essential Functions Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Technical Expertise Create and execute commissioning, qualification protocols, and validation protocols and plans (CX/IQ/OQ/PQ), including identificationand resolution of non-conformances consistent with site procedures and practices.
Provide equipment, system and facility commissioning and qualification guidance and strategy execution during project planning and development phases.
Reviews and approve technical documentation including system lifecycle design documentation (user requirements, functional and design specifications, commissioning and qualification protocols).
Perform equipment, aseptic processing, steam sterilization and process validation and their associated control systems.
Review and approve department deliverables (protocols and quality systems) Perform investigations and implement corrective actions related to CAPAs and deviations.
Developing broader skills personally by applying this knowledge to work assignments and departmentally through resource and program development.
Plan, Coordinate, and Execute assigned projects by effectively using Project Management methodologies.
Participate in regulatory inspection and response activities.
Represents validation on internal teams, committees and at technical conferences.
Report status and progress of qualification activities or projects to the Leadership team.
Leadership Skills Owns assigned Validation Plans, Procedures and Projects supporting program compliance.
Manage and directs work for assigned projects ensuring activities are on time, within budget, meet GxP and company requirements.
Possesses strong knowledge of current validation best practices, including governmental regulations and GxPs.
Demonstrated success in technical proficiency, creativity and collaboration with others through independent thought, communication and technical writing.
Provide customer focus supporting engineering, quality, manufacturing sciences and technology, and manufacturing as a Subject Matter Expert within the Validation department.
Problem Solving Proposes unique solutions to complex problems using technical proficiency, creativity and collaboration with others through independent thought, communication and technical writing.
Supports and owns process troubleshooting, operations support, root cause analysis, and risk assessment.
Uses proven monitoring and problem-solving techniques such as SPC and DMAIC.
Exercising judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
Determine methods and procedures on complex assignments and implement them after obtaining necessary stakeholder approvals.
Determining methods and procedures on complex assignments and providing technical direction and guidance to engineers within the Validation department.
Demonstrate strong leadership and management qualities when working within the department and other stakeholder groups that yield results.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties.
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
Minimum Education, Experience & Skills Due to the nature of this role and our manufacturing environment, employees are required to meet certain health and safety requirements, including the ability to adhere to the Company’s vaccination policies where job-related and consistent with applicable law.
We are committed to providing a fair and inclusive hiring process and will evaluate reasonable accommodation requests for medical disabilities, or sincerely held religious beliefs, in accordance with applicable laws.
BS Engineering/Chemistry/Microbiology or related field and/or a Minimum 8 years related industrial experience in system qualification or validation.
Expert knowledge of validation principles and concepts.
Demonstrated ability to use and operate independently within software common to Validation Departments: Microsoft (Word, Excel, Power Point), Kaye AVS.
Possesses strong knowledge of engineering and related practices, including governmental regulations – ISPE, EU, CFR 210, 211, Part 11.
