Cleaning Validation Engineer

We are seeking Cleaning Validation Engineers with a minimum of 7 years industry relevant experience.

• Are you a proactive doer
• Do you need variety and change to keep from getting bored
• Do you build relationships easily and are you able to communicate information so that it is easily understandable
• Are you able to add value for clients and anticipate their needs
• Are you able to add value for us and anticipate the needs of your role and business area
• Do you like working in a team supportive environment where others want to help you succeed
• Do you try to find a better way for everything because that is the way it should be
• Do you quickly become an expert in any subject matter you are working in
• Can you stay motivated and help motivate others in the face of adversity and change
• Are you resilient

What does it mean to be a Cleaning Validation Engineer

The Essential Duties:

Support of validation in accordance with Client requirements per Cleaning Validation Program and GxP and regulatory compliance.

Development and execution of manual cleaning validation (COP) for various manufacturing equipment and packaging lines for liquids and pastes to include:

Bracket/matrix for worst case approach

Risk assessment(s)

Sample location assessment(s)

Protocol development (verification and validation)

Parameter definition

Cleaning reports

Coordination of cleaning activities with stakeholders and floor support.

Coordination and oversight of sampling activities with Quality and Microbiology Lab resources.

Interfacing with Quality Systems for review/approval cycles and relevant Change Control support.

Regular status and deliverable communications with primary stakeholders and GMP Pros internal stakeholders.

Proactive risk escalation and management.

Status report and Steering committee meetings with executive level stakeholders.

Utilization of GMP Pros internal communication systems and Ways of Work in a project team environment.

Here are the requirements we are looking for:

Bachelors degree in an engineering field (Mechanical Chemical Biomedical preferred).

Minimum seven (7) years of proven Cleaning Validation experience in an FDA regulated industry.

Demonstrated experience with aseptic gowning requirements and clean room qualification.

Proven understanding of typical lab methods and sampling requirements for demonstrating equipment cleanliness.

Demonstrated experience with the following systems: interpreting P&IDs Process Flow Diagrams CIP skids SIP systems WIP skids CIP/COP of manufacturing and packaging equipment.

Proficiency with MS365 and relevant technology.

Ability to travel for up to one (1) week at a time.

Demonstrated knowledge and understanding of the Cleaning Validation lifecycle.

Some other things that would help you stand out to us:

Experience with Liquids and semisolids manufacturing.

Audit experience.

ISPE Pharma 4.0 training specific to validation.

Selfguided and managed execution of Cleaning Validation program.

Cleaning Validation experience in a remediation setting.

Preferred Qualities and Traits:

Must be driven to seek out new opportunities ask questions and keep pursuing things when information is limited or not given at all.

Must be able to quickly turn information received into concise verbiage on paper. Complete stories must be told of events that occurred and actions to be taken but should not use fluff.

ACTUALLY listen to everyones input before forming your thoughts or replies. Operators and others in the facility have a wealth of process and product knowledge. Some are limited to their specific trade so it is your job to take their information to the next level and fit it into the bigger puzzle.

In this fastmoving industry things will change continuously. Must be able to adapt to the changes and continue making progress.

Must be patient and focused while also having a continuous sense of urgency.

Must be able to perform work under rigid timelines in support of client success.

PreEmployment Requirements:

Pass and maintain precontract background check and safety certification including but not limited to outstanding professional references.

Subject to motor vehicle report review.

Maintain valid drivers license and endorsements as required per position.

Pass precontract physical medical evaluation and drug screen due to the safety sensitive nature of this position.

Successfully complete and maintain any required safety certification and testing on an annual basis.

Key Words: Cleaning Validation Validation Engineer Risk assessment Bracket/matrix Protocol development (verification and validation) Parameter definition Cleaning reports.