Americans with Disabilities Act (ADA), Analysis Skills, Asepsis, CIP (Clean-in-Place), Change Control, Change Management, Commissioning, Continuous Improvement, Cross-Functional, Current Good Manufacturing Practice (cGMP), Detail Oriented, Documentation, Drug Manufacturing, Drug Products, Establish Priorities, FDA (Food and Drug Administration), Follow Through, Information Technology & Information Systems, Interpersonal Skills, Laboratory, Leadership, Lean Six Sigma, Physical Demands, Problem Solving Skills, Procedure Development, Process Improvement, Quality Assurance, Regulations, Regulatory Requirements, Requirements Management, Requirements Validation/Verification, SIP (Sterilization-in-Place), Standard Operating Procedures (SOP), Standards Development, Systems Analysis, Team Player, Temperature Mapping, Testing, Time Management, Validation Plan
Position Summary
Validation Engineer II will be responsible for leading the commissioning, qualification, and validation (CQV) for a newly announced facility expansion for biologics that includes a dedicated cGMP utilities systems (clean steam, compressed air, nitrogen) high-speed cartridge filling line, significant utilities upgrade, dedicated formulation and processing suites, with Clean In Place (CIP) and Sanitize In Place (SIP) capabilities. Working closely with system owners and related stakeholders (operations, engineering, laboratories, IT, and quality assurance) this role will guide CQV activities to a compliant state throughout their lifecycle. This includes authoring, review, and execution of related CQV documentation as well as related documents for the role (e.g., procedures and change control records). Serves as subject matter expert for CQV activities.
Essential Duties and Responsibilities:
- Lead the development and execution of commissioning, qualification, and validation protocols for various equipment, systems, and critical utilities (CCA, N2, Clean Steam).
- Responsible for all phases of the CQV activity, including all phases: defining requirements, validation planning, protocol generation, final summary report generation, test execution, configuration documentation, system release, periodic requalification’s’ and periodic system monitoring evaluations.
- Executes validation activity in a timely manner, planning and proactively pursuing details to ensure project completion without avoidable delays.
- Evaluate System Change Controls for Validation Impact. Support Change Qualification through the creation of relevant Change Actions.
- Support the development of Standard Operating Procedures for new processes and equipment.
- Interpersonal skills to manage interactions and achieve results across a range of functions within the site. It may also extend to external communication with system vendors.
- Serve as Principal Investigator for validation-related excursions.
- Contribute to the continuous improvement of validation processes and procedures.
- Bachelor’s degree in engineering or relevant sciences and 8+ years of CQV experience.
- 8 years’ experience with sterile injectables, combo-devices, or biologics.
- Advanced degrees or certifications relevant to the role is a plus.
- Knowledge of regulatory requirements (cGMP, FDA, etc.).
- Experience authoring, approving, and executing validation protocols for major pharmaceutical manufacturing facilities, utilities, and equipment.
- Self-directed with problem-solving, analytical, and technical skills.
- Ability to think strategically and tactically (detail-oriented).
- Experience in a sterile fill-finish facility.
- Experience with single-use components in drug product formulation, sterile filtration, and aseptic filling applications.
- Start-up experience preferred.
- Experience with validation tools and processes, including temperature mapping and use of Kaye Validator.
Basic Qualifications and Capabilities:
- Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment.
- Ability to lead, take ownership, and follow through on assigned projects.
- Demonstrated ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
- Experience in a process improvement environment, including change management and participating in Lean/Six Sigma project teams.
- Ability to own, lead and drive CQV program improvements and new program implementation for validation gaps identified.
- Ability to work autonomously within established guidelines, procedures, and practices.
Preferred Qualifications:
Physical Demands and Work Environment:
The physical demands described here are representative of those that an employee must meet to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.
While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 40 pounds. The noise level in the work environment is usually low to moderate.
The company is an Equal Opportunity Employer, drug-free workplace, and complies with ADA regulations as applicable.