Validation Engineer/Specialist ( Mid to Senior Level)

Company: Mangan Inc
Location: Cary
Posted on: September 25, 2022

Job Description:

Validation Engineer/Specialist (Mid to Senior Level)Location: Cary, NCMangan Biopharm is a subsidiary division of Mangan Inc. and is a full-service Engineering and Life Science Quality and Compliance Company. Mangan has over 25 years of experience in Engineering, Procurement and Construction with 15+ years of experience in Lifesciences Engineering and Compliance Consulting. We are customer-centric and fully committed to our clients' needs and as a result, most of our business is repeat business. We are an employee owned company with opportunities for growth.Position Summary:The Validation Engineer/Specialist is responsible for execution of validation projects for equipment, facilities, and utilities in a pharmaceutical manufacturing, packaging, or support environment. The candidate must be able to work independently, but be able to coordinate execution efforts with operations, manufacturing, facilities, laboratories, development, materials management and quality assurance personnel. This role will play an integral part in overall project success.Duties:Analyze validation data, prepare summary reports and provide recommendations forimprovement in manufacturing process and equipmentDevelop training packages, JSAs and writing Best Known Methods (BKM) for ValidationServe as a dependable liaison between validation and manufacturingIdentify, respond to and monitor potential project risk and determine possible contingency plansfor risk mitigationReviews technical and quality system documents such as SOPs, Change Control and DeviationReports, Batch Production Records, Technical Manuals, P&IDs, construction, as-built, flow diagrams as they relate to validation principles and regulatory compliance issues Requirements:5+ years' experience Education: BS in technical field is a plusOther Skills/Qualifications: Good understanding of cGMP validation requirements / guidelines and current industry practiceResults-oriented, able to make decisions, and able to prioritize validation project and client needsExcellent organization and time management skillsStrong teamwork and collaborationMust have excellent interpersonal, technical writing and communication skillsProficient in use of MS Office software suiteBenefits:Competitive salary with a discretionary bonus potentialBenefit Time Off (BTO) that can be used as paid vacation, sick time, holiday funding, or as cash-outEmployee Stock Ownership Plan (ESOP) & 401(k) plan for retirement with employer matchCompany funded health and dental insurance with low employee cost sharingWellness & Vision subsidyCompany paid short term and long term disability coverage

Keywords: Mangan Inc, Cary , Validation Engineer/Specialist ( Mid to Senior Level), Engineering , Cary, North Carolina