Principal Validation Engineer

Job SummaryThe Principal Validation Engineer is a Manufacturing Operations subject matter expert who actively collaborates with quality, regulatory, manufacturing, engineering and global I&D teams. Responsible for providing technical support to operations in terms of equipment/system initial validation and equipment/system requalification. Will participate in equipment improvement teams charged with enhancing the compliance and performance of plant systems, while considering the regulatory requirements for change control. The individual must have a comprehensive understanding of cGMPs and become certified to enter controlled areas of the plant.

Salary Range: $90,816-$130,000 annually + 10% annual bonus

Final pay determinations will depend on various factors, including, but not limited to experience level, education level, knowledge, skills, and abilities.Responsibilities

• Provides technical expertise and guidance to all manufacturing facilities and third-party manufacturing department.
• Evaluates and implements best practices for  the  manufacturing facility designed  to  provide robust manufacturing  processes  and within the department designed to provide harmonized and efficient processes.
• Generate innovative solutions to complex problems through the use of multiple disciplines and technical principles.  Advises senior management regarding appropriate action.
• Communicates plant issues and tasks with the project team with respect to scaling up processes, new equipment and procedures, equipment validation, manufacturing of development, stability, and product validation batches.
• Communicates as necessary with the various plant departments, other support  departments, project team members,  and own department.   Is expected to be responsible for those new projects with a high level of difficulty.
• Authors protocols for equipment qualification and the manufacture of  development,  stability, and validation batches.
• Interfaces with the FDA and other regulatory bodies on technical topics.
• Provides information and documentation needed for regulatory submissions or responses as required.
• Plant liaison for manufacturing processes to other departments within the site, other business units within the company, and marketing  units.   Serves as the plant point of contact for channeling  all manufacturing related questions and issues for resolution.
• Technically assesses changes in manufacturing through appropriate review of documentation and testing results.   Reports changes through risk assessments.
• Provides technical support for Investigations, Action Plans  and Material  Change  Requests, etc. as required. Generate innovative solutions to solving difficult problems that may impact multiple disciplines.  Advises management regarding appropriate action.
• Develops and executes necessary investigative studies and validation protocols as required.
• Conducts Validation deviations and/or participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA).
• Reviews  as required various validation documentation with regulatory and  other appropriate groups
• Identifies project requirements and facilitates requirements with outside customers and vendors, as required.
• Approver for qualification, validation, and periodic review protocols and final reports.
• Mentors employees in the department and supports their development.
• Provides first level of support and direction to departmental staff members as required.
• Technical reviewer or approver for tables and protocols and final reports (as assigned by manager).
• Actively participates in leadership training.
• Serve as a designee as assigned by the Validation Manager.
• All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities.

Requirements

• Minimum of a bachelor's degree in science, engineering, or equivalent experience.
• Must possess good interpersonal skills to establish effective working relationships that are critical in a team environment
• Effective oral and written communication skill set. Requires proficient presentation and technical writing abilities
• 8+ years' experience desired  with validation, qualification, or technology transfer assignments that demonstrates the tenacity to see projects through to completion according to established action plan; analytical skills necessary  for problem solving issues as they arise
• Understanding of statistical analysis tools and methods.
• Knowledge and experience in cGMP, industry guidance, aseptic techniques, CA/PA, root-cause analysis, risk assessment and investigation tools and techniques.
• Knowledge of parenteral product development, manufacturing processes, validation, cGMP's and FDA regulations for the Pharmaceutical Industry.
• Work under minimal supervision on all projects with high level of difficulty.
• Typical work hours are the standard first shift, however execution of protocols may require work on nights and weekends to meet the production schedule. Flexibility with schedule is required.
• Schedule based on a 40 hour work week with the number of hours per day and weekends flexible to support protocol execution or project oversight.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

---