Primary Duties: As part of an overall cross-functional Commissioning, Qualification and Validation (CQV) approach to laboratory equipment/instruments the Validation Specialist will be involved in all aspects of CQV within a US and EU GxP regulated environment.
Under the general guidance of the Validation Leader, the Validation Specialist will independently manage contractors, the overall development, implementation of GLP/Non-GLP equipment/instruments, and system lifecycle documentation. This includes: Validation Plans, User Requirements Specifications, Design Qualifications, Testing Protocols (IQ/OQ/PQ/DQ), Validation Summary Reports, Revalidation & Periodic Reviews, SOPs, Change Control Documentation and Risk assessments.
Responsibilities include but are not limited to:
- Provide leadership and technical support for the validation group
- Establish project timelines and expectations, ensuring compliance to validated parameters
- Providing technical consultation to area supervisors as it relates to quality, safety, and environmental requirements, and appropriately investing in new technologies to ensure continued compliance.
- Work with Validation Managers to define, recommend, and justify validation budgets, capacity, personnel, and capital equipment needs.
- Interface with management personnel in Engineering, Manufacturing, Regulatory Affairs, etc.
- Participating in implementation of Validation policies and procedures.
- Provide leadership and technical decision-making regarding cGMP compliance, regulatory issues, validation strategy, and quality systems.
- Prepare and present technical investigative reports.
- Evaluate, select and coordinate contract assistance in generating validation protocols and reports.
- Lead cGMP training programs related to facility and equipment.
- Support Validation Manager and Director by interacting with regulatory authorities during Site inspections relative to facility and equipment cGMP areas; supports successful management of inspections.
- Ensures Self Inspection procedures for area of responsibility are in place and in use. Participate in a sampling of Self Inspections for the area(s) of responsibility.
- Perform other functions as necessary or as assigned.
- Lead the CQV planning, development, and implementation of GLP and Non-GLP laboratory equipment/instruments and utilities for all levels of projects.
- Review/approve and execute the validation documentation for facilities, manufacturing and laboratory equipment, shipping, utility systems and process equipment including cleaning validation.
- Manage validation contractor activities for projects and ongoing operations.
- Represent validation during the creation of Validation Strategy Documents and other project related documentation.
- Initiate and participate as appropriate in associated change control requests, deviations, CAPAs and equipment acquisition documentation.
- Responsible for all projects assigned. May act as an advisor to team members to meet schedules or resolve technical or operational problems. Is cognizant of schedules, and performance standards in how they relate to work assigned.
- Works under consultative direction to perform corrective actions to address validation discrepancies and identified measurement problems. Work checked through consultation and agreement with others rather than by formal review of superior. Champion continuous improvements by developing best and proven practices in the department based upon current industry, US and EU guidelines.
- Ensures schedules, and performance requirements are met.
- Leads the development and maintenance of validation related Master Plans, SOPs, work instructions, and forms.
- Will represent function on specific projects, conduct briefings and technical meetings for internal and external representatives, as needed.
Education and Experience Requirements:
- BS degree in engineering or a life sciences field is required.
- A minimum of 7-10 years of experience in validation within a GLP regulated environment (FDA, EU, MHRA).
- Demonstrated technical project management experience to develop project goals, deliverables and timelines.
- Proven experience developing full validation documentation and testing protocols (IQ/OQ/PQ/DQ) for GLP laboratory equipment/instruments.
- Demonstrated working knowledge of Good Engineering Practices, ASTM E2500, USP 1058, 21CFR Part 11, GAMP5 as they relate to equipment/instrument qualification.
- Strong working knowledge of GxP compliance as well as USP, EP, ICH and FDA guidelines
- Previous work experience with automated lab systems and robotics is highly desirable.
Key Skills, Abilities, and Competencies:
- Direct exposure and experience in a GLP/Validation discipline with a knowledge and understanding of laboratories and how they relate to US and EU regulatory requirements and expectations
- Possess the ability to multitask and work independently or in a team environment with minimal supervision
- Possess good interpersonal and strong written/verbal communication skills
- Well developed skills in prioritizing, organization and time management
- Highly motivated and detail oriented with good organizational skills
- Ability to work in a dynamic, fast paced environment with shifting priorities
- “Hands-On” problem solving.
Complexity and Problem Solving:
- Works on complex problems where analysis of situations or data requires evaluation of various factors including application of basic statistics. Exercises judgement within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Ensures schedules and performance requirements are met.
- Builds productive relationships internally and externally.