Validation Engineer

Position Summary

As a Validation Engineer you will be responsible for validating/qualifying the manufacturing and cleaning processes used in the manufacturing of topical drug products within a large manufacturing facility located in North Carolina, USA. You will ensure that processes are repeatable and meet all defined requirements to ensure the production of quality products.

Summary of Key Responsibilities:

• Execute multiple large- and small-scale projects.
• Prepares and executes URS, FAT, SAT, and IOQ requirements for new equipment and systems.
• Executes process and cleaning validation studies to include protocol preparation, scheduling, protocol execution, data analysis, and composition of a final report.
• Schedules and executes validations/qualifications per Standard Operating Procedures (SOPs) and regulatory guidelines.
• Coordinates and communicates all testing with affected functional groups and evaluates test results.
• Participates and presents data in Regulatory Agency, Customer, Corporate and Internal audits.
• Provide technical expertise to define approaches and execution of system validation activities in accordance with cGMP, cGXP, CFR 21 Parts, 11, 210 & 211, EU Annex 11, ICH Q7, Q8 & Q9, and other applicable regulations, procedures and industry guidelines.
• Participates in developments/ improvements to validation programs as needed to remain current with cGMPs and industry standards.
• Participates in teams assembled to specify, install, validate, troubleshoot and maintain systems and equipment.
• Conducts validation deviations and/or participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CAPA).

Supervisory responsibilities

• May provide technical leadership and mentorship to junior validation engineers or contractors
• Lead training initiatives related to cleaning validation processes and compliance

Key Relationships:

• Manufacturing Operations
• Quality Assurance & Quality Control
• Analytical Development / Laboratories
• Engineering & Facilities
• Project Management
• Regulatory Affairs
• Clients / External Auditors

Travel requirements :

• Minimal travel required; occasional travel for client meetings, audits, or regulatory inspections

Required Qualifications and Skills:

• BS/BA degree in science, engineering, manufacturing technology or closely related field with 3+ years of relevant experience, required.
• Excellent attention to detail and working knowledge of FDA Regulations/Guidance and/or Good Manufacturing Practices.
• Technical knowledge and experience with validation/qualification of processes, equipment, utilities, facilities and/or computer systems, required. Knowledge and experience of the above, as related to sterile products and medical devices, is preferred.
• Experience in pharmaceutical industry is strongly preferred.
• Must be proactive, have experience with high performance teams, as well as strong interpersonal and project management skills.
• Must be able to interact with varying levels within the company.
• Ability to work both independently and in partnership with others; proven ability to use initiative and drive to achieve results.
• Strong conflict resolution skills.
• Must be able to work multiple shifts as needed to meet deadlines.

Physical Demands and Work Environment

While performing the duties of this job, there may be certain physical demands required for the position:

• May be required to stand for extended periods within manufacturing environments
• Occasional lifting of materials or equipment (up to 20 kg)
• Exposure to GMP manufacturing areas including cleanrooms, laboratories, and production suites
• May be exposed to varying temperatures, chemicals, and moderate noise levels in manufacturing settings

Other Duties

You may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked.

Limitations and Disclaimer

The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position. The Company is committed to making reasonable adjustments to the workplace to ensure the role is accessible to all candidates, including those with disabilities. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.