Auftragsdetails

Our client has a staff augmentation need for multiple Process Validation Consultant for a 3-month, on-site engagement at their Kansas City, MO facility. This resource is needed for on-site CQV support of various manufacturing and lab equipment. The clients Process Validation team facilitates at-scale mixing and hold studies, qualifies new products, and maintains the media fill program. Responsibilities include, but are not limited to: 

• Coordinating multiple projects
• Documenting activities via protocols and summary report templates to help establish new templates and policies as needed 
• Reviewing facility changes and providing input on re-validation
• Assessing risks involved in processing steps and related to equipment
• Developing and/or reviewing validation requirements and design deliverables
• Partnering with contract validation teams to support and monitor efforts
• Monitoring validation strategies, ensuring polices are followed, conducting validation studies in accordance with batch records/protocols, and identifying exceptions associated with validation protocol execution

• Qualified candidates will possess a Bachelor’s degree in related field along with 2 plus years related industry experience.
• Candidates must have excellent verbal communication and technical writing skills.
• Experience in executing protocols including systems such as Process Validation, computer controlled systems validation, utilities, manufacturing equipment such as computer controlled filling systems, formulation systems and basic knowledge of laboratory validation (not required but preferred).
• Familiarity with many aspects of validation is expected.
• Experience with temperature mapping.
• Proficient in Microsoft Word, Excel, Power Point and Project.
• Must be willing to travel regionally and/or nationally throughout the US.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties.  Please, no phone calls or emails to anyone regarding this posting.***