Hyde Engineering + Consulting ยท 16 hours ago
Cleaning Validation Engineer
Raleigh, NC
Full-time
Onsite
Mid LevelHyde Engineering + Consulting is an employee-owned firm comprised of industry experts looking to make a meaningful impact for biopharmaceutical and pharmaceutical clients. The Cleaning Validation Engineer is responsible for cleaning and process engineering and validation, generating and executing testing for multiple phases of commissioning and qualification in a cGMP facility.
Pharmaceuticals
Hiring Manager
Jen Moore
Responsibilities
Generate, execute, and report on testing for multiple phases of commissioning and qualification
Post cleaning validation monitoring, cleaning cycle development and cleaning validation in a cGMP facility
Experience in CIP/COP and manual cleaning validation activities is required
Troubleshooting CIP system failures, optimizing CIP/COP systems including manual processes and CIP equipment, developing CIP/COP Cycles is preferred
Developing documents and SOPs and prepare reports is required
Analyze data, determine results and present conclusions and recommendations ensuring that projects are implemented in accordance with the agreed scope timelines, policies and procedures
Generate and resolve protocol discrepancies or deviations
Review GxP deliverables including specifications, drawings, procedural documents, master plans, and validation documentation
Train operations staff on protocols, procedures and technical details related to systems or processes
Organize, schedule and track validation projects in order to meet client requirements and agreed timelines
Qualification
Required
Experience in CIP/COP and manual cleaning validation activities is required
Experience Developing documents and SOPs and prepare reports is required
Must have experience analyze data, determine results and present conclusions and recommendations ensuring that projects are implemented in accordance with the agreed scope timelines, policies and procedures
Generate and resolve protocol discrepancies or deviations
Review GxP deliverables including specifications, drawings, procedural documents, master plans, and validation documentation
Train operations staff on protocols, procedures and technical details related to systems or processes
Organize, schedule and track validation projects in order to meet client requirements and agreed timelines
Hands-on experience with the following systems: CIP systems, SIP systems, cabinet washers, COP, manual cleaning is required
Working knowledge of cGMP requirements and strong written and verbal communication skills are required for this position
Strong problem solving and decision making skills
Ability to understand and extract necessary information from technical documents
Ability to handle complex projects
Takes initiative to help drive projects forward and develop contingency plans when applicable
Ability to work on cross-functional project teams
Able to effectively manage workload and prioritize activities
Excellent verbal and written communication skills
Proven ability to review, interpret and make scientific conclusions and recommendations based on data
Ability to work independently, handle multiple tasks simultaneously and to meet critical milestones and goals
Effectively work within a team environment and interface with peers, management, etc
Strong computer skills, including experience using Microsoft Word, Excel, PowerPoint and Visio
Preferred
Experience troubleshooting CIP system failures, optimizing CIP/COP systems including manual processes and CIP equipment, developing CIP/COP Cycles is preferred
Experience with sampling techniques
Experience with development of manual cleaning protocols for Tablet press equipment is highly preferred
Experimental design and problem solving skills are preferred
Strong organizational skills and demonstrated ability to manage projects to completion are highly desired
Experience in discrepancy and non-conformance reporting, corrective action/preventive action systems and root cause analysis is preferred
Company
Hyde Engineering + Consulting
Hyde E+C is an international engineering consulting firm that helps companies operate more efficiently, get products to market more quickly, meet regulatory requirements more reliably, and conserve precious resources more consistently.
Founded in 1993
201-500 employees
H1B Sponsorship
Hyde Engineering + Consulting has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (9)
2023 (9)
2022 (14)
2021 (15)
2020 (15)
Funding
Current Stage
Growth StageLeadership Team
Kerren Bergman
Chief Executive Officer
Ronald Berk
CTO and Principal Consultant
Company data provided by crunchbase