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This Project Lead position is responsible for performing, completing, and helping to manage validation assignments.

Essential Functions Include:

• Perform all job functions of Senior Validation Engineer.
• Manage project financial and project progress reporting for management and client reports.
• Supervise multiple individuals for the duration of a particular validation project.
• Execute multiple tasks or projects.
• Perform complex validation assignments, quality assurance assignments (where applicable) and other related job assignments as may be necessary for execution of the specific job activities.
• Execution for multiple systems validation.
• Development summary documents for complex systems such as utilities, filling systems, lab equipment systems, computer-controlled systems at a minimum.
• Execute protocols including complex systems such as process validation, computer controlled systems validation, complex utilities, complex manufacturing equipment such as computer controlled filling systems, and formulation systems.
• Fulfill supervisory responsibilities in accordance with the organization’s policies and applicable guidelines. 
• Participate in in-house staff training.
• Plan, assign, and direct work.
• Enforce human resources policies and procedures with support of human resources staff.
• Promote the firm’s reputation through good client relations. 
• Provide leadership in client retention. 
• Extensive travel required.
• Other duties as assigned.

Qualified candidates must have:

• B.S./B.A in Engineering or Science or related field as a minimum.
• 4 years’ relevant work experience in lieu of education requirement.
• Minimum 5 years’ experience in the field of validation or
• 6+ years’ experience in related industry.
• Minimum 1-year management experience required.
• Minimum 1-year supervision experience required.
• Experience in executing protocols including complex systems such as Process Validation, computer controlled systems validation, complex utilities, complex 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. Depth in one or several areas is critical.
• Experience in one or more validation subjects, such as laboratory equipment, facilities utilities, process equipment, packaging equipment, cleaning, computers, HVAC, or controls.
• Understanding of FDA cGMPs, FDA Guidelines and European Guidelines (where applicable).
• Proficient with Microsoft Project.
• Working knowledge of Microsoft Word, Microsoft Excel.
• Ability to collaborate with multiple individuals (where applicable); ability to execute multiple tasks associated within the validation field.
• Ability to monitor and report on the execution of multiple validation tasks on a routine basis. Ability to read Engineering Drawings including but not limited to, P&IDs, Process and Utility Flow Diagrams, HVAC diagrams, Equipment Drawings, and Instrumentation Drawings.
• Experience in the utilization of various temperature monitoring devices, including Kaye dataloggers, etc. Experience in the utilization of other monitoring equipment such as Short Ridge, Met One particle counter, etc.
• Experience in development of Standard Operating Procedures (SOPs).
• Experience in Process Qualification execution.
• Ability to read, prepare and analyze data for development of reports, ability to read and assemble summary documents as required.
• Experience in project execution for multiple systems validation.
• Significant experience in one or more validation subjects, such as laboratory equipment, facilities utilities, process equipment, packaging equipment, cleaning, computers, HVAC, or controls.
• Experience in development of summary documents for complex systems such as utilities, filling systems, lab equipment systems, computer-controlled systems at a minimum.
• Experience in executing protocols including complex systems such as Process Validation, computer controlled systems validation, complex utilities, complex 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. Depth in one or several areas is critical.
• Ability to manage project financial and project progress reporting for management and client reports.
• Ability to supervise multiple individuals for the duration of a particular validation project.
• Ability to execute multiple tasks or projects.

• Ability to walk, stand and move about for extended periods of time; work with equipment in the field including basic hand tools, lift and manipulate reasonable weights (approximately 35 lbs.), ability to sit and type for extended periods of time.

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.***