Validation Engineer (CQV/CIP)

Description:

No C2C (Only w2)

Fully onsite - 8-5 Monday - Friday - occasional availability needed outside normal hours such as nights or weekends.

Ideal candidate: 8 YOE Must have field execution experience.

Day to Day Responsibilities:

• Lead the execution of all Cleaning Validation activities (CV/SIP PQ/CHT/SHT studies), including protocol generation, field execution, data retrieval/verification, sample management following a Lifecycle Approach and using Kneat.

• Supports non-traditional work schedule based on project and business needs

• Leads and performs on floor CV execution and sampling. Provide technical support and sample management to cleaning activities associated with the manufacturing process.

• Design and develop cleaning procedures for new products and manufacturing equipment.

• Conduct cleaning validation studies, including sampling, testing, and data analysis.

• Investigates and conducts troubleshooting/root cause analysis of cleaning related incidents, deviations and cleaning out of specification results for non-validated or under development cleaning procedures.

• Performs successful and on time resolution of incidents and deviations related to cleaning validation exercises.

• Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering, to ensure cleaning validation activities are integrated into the overall project plan.

• Trains manufacturing and QC/QA personnel on cleaning validation documentation.

• Support the development of the periodic cleaning monitoring program.

• Benchmark against the broader network and external industry with the aim of achieving best-in-class standards and practices, expands and shares knowledge throughout the network to achieve excellence in Cleaning Validation.

• Support assigned teams as required to provide Cleaning Validation guidance.

• Review and coordinate Change Controls with Cleaning Validation impact as required.

• Lead and support continuous improvement by identifying and implementing projects to eliminate waste and improve cleaning times through CIP Optimization.

• Perform risk assessments to identify potential contamination sources and establish appropriate cleaning procedures

Basic Qualifications

Doctorate degree OR Master’s degree and 2 years of experience OR Bachelor’s degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience

Top Must Have Skill Sets:

Proficient with KNEAT

Demonstrated track record of leading and executing cleaning validation studies and knowledge of CV lifecycle

Proficient with CIP/SIP cycles and process understanding to drive execution of validation deliverables

Willingness to work non-traditional shift, off shift, weekends, and holidays to support cleaning validation activities as needed

Demonstrated proficiency in utilizing PI for run trending analysis and facilitating the successful completion of support packages.

Effective communication and collaboration skills to work across teams.

Leads and performs on floor CV execution and sampling. Provide technical support and sample management to cleaning activities associated with the manufacturing process.

Field execution experience

Nice to have: PM experience, troubleshooting deviation CAPA change control management, ability to support investigational studies as needed.