Cleaning Validation Engineer

Company Name:
Hyde Engineering + Consulting
Since 1993, Hyde has been a worldwide leader and global service provider to pharmaceutical and biopharmaceutical industries. Our projects result in the successful design, construction, commissioning, and validation of manufacturing facilities and equipment.
As a member of the Hyde team, you'll be part of providing state-of-the-art solutions for some of the industry leaders. As we continue to grow our operations around the world, we need the best talent--men and women dedicated to quality and innovation. We offer a collaborative culture, challenging projects, and excellent compensation and benefits. You will find these values reflected in our company:
Family Happiness
Integrity
Friendship
Wisdom
Adventure
Position: Cleaning Validation Engineer
The position involves 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. Experience troubleshooting CIP system failures, optimizing CIP/COP systems including manual processes and CIP equipment, developing CIP/COP Cycles is preferred. 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, cabinet washers, COP, manual cleaning is required.
Experience with sampling techniques.
Experience with development of manual cleaning protocols for Tablet press equipment is highly preferred.
Working knowledge of cGMP requirements and strong written and verbal communication skills are required for this position.
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.
Qualifications:
Strong Demonstrated 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.

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