SR. Cleaning Validation Engineer

Responsibilities associated with this position include maintaining qualified state of cleaning processes and procedures as well as design and implementation of new cleaning processes. The candidate must be well organized and technically sound in understanding of cleaning validation principles including development of acceptance criteria, within a pharmaceutical or medical device manufacturing environment. Strong technical writing including protocol generation, deviation investigation and generation as well as report writing is required. The candidate must be a team player, who thrives in a team environment, but also has the ability to work on their own. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Generation and execution of cleaning validation protocols including the generation, routing and approval of summary documentation. Must be able to read and understand engineering P&ID’s and turnover documentation. Work with project teams to develop new cleaning processes as well as perform cleaning development studies and sprayball coverage studies. Generate and maintain cleaning validation master plans. Scheduling coordination, material allocation and management of contract employees when required in order to successfully complete validation assignments. Understanding of proper sampling technique for swab and rinse samples. Abiility to determine and document cleaning validation acceptance limits for process soils. Develop cleaning validation sampling plans and collect swab and rinse samples within manufacturing environment. Ability to investigate and resolve deviations or non-conformances. Ensure that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements. Support and address comments and suggestions associated with validation and engineering documentation. Change control, non-conformance and CAPA support. Participate in FDA inspections, ISO certifications, surveillance audits and customer audits. Knowledge of cleaning validation test method development a plus. The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

• Bachelors Degree in Engineering (Biomedical, mechanical, chemical, or electrical) or Science (Biology, Chemistry).
• 5 to 7 years of experience in a Validation or Quality Assurance role for medical device or pharmaceutical environment.
• 2-3 years specializing in cleaning validation or serving as cleaning validation lead.
• Demonstration of excellent organizational and communication skills.
• Results oriented with a strong focus on quality principles.
• Proficient with the MS Office Suite, experience with Microsoft Visio a plus.
• Must be able to work independently with minimal supervision.
• Excellent technical writing skills with a thorough understanding of good documentation practice.
• Ability to prioritize projects and manage assigned resources to meet organizational goals and objectives.
• Ability to track and update schedules to provide upper management visibility of milestones and achievements.

SKILLS AND CERTIFICATIONS