ProPharma Group Equipment/Cleaning Validation Support Project Manager - Lexington, MA (REF7204V) in Boston, Massachusetts
Support the commissioning of a V-Blender and Sachet filling line.
Assessing equipment to define the commissioning plan and authoring the IQ/OQ protocol/reports for the V-Blender.
Support the closing out of the IQ/OQ protocol/report for the filling line.
Preparing and executing validation documents.
Project execution for multiple systems validation.
Understanding the hours budgeted for completion of each task on a specific.
Individuals must represent the company and division at client sites and interact confidently with clients, contractors, management and peers.
Develop Installation, Operational and simple Performance qualification documents.
Qualified candidates will possess a Bachelor’s degree in related field along with 10 plus years related industry experience.
Solid GMP manufacturing experience to assist operators with development runs and process troubleshooting.
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.
All candidates must be legally eligible to work in the United States.
We are an equal opportunity employer. M/F/D/V
ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.