Pharmaceutical manufacturer on the south side of Charlotte, NC. Strong growth potential and very active team/family environment.
We are actively seeking a Sr. Validation Specialist to be an individual contributor to the Validation Department with an emphasis on Equipment Qualification. Additional responsibilities include but are not limited to: Cleaning, Critical Utilities, Facilities, and Process Validation. Reporting into the Validation Manager, the Validation Specialist has responsibilities for all aspects of planning, coordination, development, execution and close out of commissioning, qualification and/or validation protocols/reports meeting quality and schedule expectations.
As the Sr. Validation Specialist, you will perform installation and operational and performance qualification (IQ/OQ/PQ) of critical manufacturing equipment, facilities, and utility systems for Sterile Manufacturing facilities.
The position requires knowledge of cGMP and associated industry and regulatory guidance documents. The candidate must have demonstrated proficiency in project management skills and must be able to balance multiple priorities. Main responsibilities include:
? Equipment Qualification - development of validation protocols, testing execution and writes validation reports. This includes FATs, URSs, DQs, SATs, CTPs, IQs, OQs, PQs, and other validation life cycle document.
? Cleaning and Process Validation – assists/performs cleaning and process validation at the site.
? Adhere to all company and GMP procedures, along with safety regulations within the plant. ? Assist with the Site Change Management Program to keep all finished products, equipment, processes and facilities in compliance with contemporary industry standards and regulatory filings.
? Develop a strong documentation package, involving pre-commissioning/commissioning of equipment, Qualification and documentation
? Conduct regular project review meetings within the team, with cross functional teams and with the vendors to control the project time to time.
? Stay current with industry qualification trends through FDA, ISPE, EU, PDA and bench marked companies.
? Bachelor’s degree required, preferably in Engineering, Chemistry, Microbiology, or Pharmaceutical Sciences
? A combination of education and relevant experience will be considered.
? Minimum of eight (8) years of relevant validation experience in the pharmaceutical industry.
? Demonstrated experience and a high level of experience validating a wide range of equipment and processes in Sterile production environments (cleaning processes, sterile filling, freeze drying, depyrogenation, parts & vial washers, wet/steam/dry heat sterilization, pre-filled syringe filling, vial filling, Nebulizer filling, and packaging).
? Demonstrated working knowledge of FDA and CFR regulations, and other applicable industry regulations and standards
? Demonstrated experience and knowledge of qualifying changes to validated systems/processes/and equipment.
? Strong Knowledge and understanding of validation and qualification principles, and Quality Systems principles (Change Control, Non-Conformance and CAPA). ? A solid base and application experience in sterile pharmaceutical manufacturing plants, and/or related environmental projects, material handling, containment, and utility/infrastructure support facilities.
? Demonstrated ability to effectively communicate and collaborate across all levels of the organization including with customers, vendors, equipment suppliers, and Operations staff.
? Strong understanding of aseptic techniques, gowning techniques, assembly of aseptic processing lines and room classifications is required.
Knowledge & Skills:
? Must be able to work independently and in team environment: plan, organize and prioritize work.
? Must be able to lead project with minimal supervision.
? Ability to analyze quantitative data, create and/or edit written reports and be able to process information.
? To perform this job successfully, an individual should have an advanced knowledge of Microsoft Office (Word, Excel, Outlook, Access, and Project)
? Strong attention to detail.
? Ability to read, analyze and interpret common scientific and technical journals; comprehend equipment manuals and translate operational limits into protocols acceptance criteria.
? Ability to define problems, collect data, establish facts, and draw valid conclusion; interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract or concrete variables.
? Knowledgeable on aseptic techniques, gowning techniques, assembly of aseptic processing lines and room classifications.