Auftragsdetails

Our client requires a Senior Consultant to support Validation Master Plan (VMP) development and medical device validation support. Duties and responsibilities to include, but are not limited to:

• Generate the master validation plan for combination product assembly, packaging and labeling and a validation plan appendix for a specific combination product.
• Assist with generating procedures to govern the design transfer of a combination product to manufacturing and process development activities.
• Develop process development strategy for a combination product
• Provide oversight to process development protocol generation and execution and oversight to process development summary report generation.
• Participate in pFMEA for combination product manufacturing processes including assembly, packaging and labeling.

• BS in Biomechanical, Mechanical or Chemical Engineering, or applicable Science/Engineering degree.
• A minimum of 7 years of experience in the medical device industry for combination products, including experience with assembly, packaging and labeling process validation.
• 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.***