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Project Manager / Sr. Project Manager – Commissioning, Qualification and Validation (CQV)

Responsibilities
Responsible for the overall project execution and project deliverables related to Commissioning, Qualification and Validation of pharmaceutical, biotech and AMTP facilities, laboratory and manufacturing equipment and processes. Responsibilities are expected to include but are not limited to:

• The Project Manager will be responsible for developing project scope statements, estimates and staffing plans.
• Project Manager will interface with clients, lead teams of validation professionals, and provide subject matter expertise in the validation of a variety of utility, facility and process equipment.
• Project Management experience in managing scope, cost, schedule, quality, and risk is required.
• Train and mentor newer validation engineers.

Requirements
• Minimum of 10 years experience with increasing responsibility in validation/quality service and project management of life sciences, biotech or other FDA regulated projects.
• Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for validation of GMP facilities.
• Strong organizational skills, excellent writing and communications skills.
• Must be able to work independently and in a team environment, interacting with individuals at all levels in an organization and departmental areas.
• Ability to be flexible to address both shifting priorities and changes in approach in dynamic work environments.
• Strong understanding of EPCMV, Quality by Design and risk-and science-based approaches and tools for compliance are desired.
• Strong leadership, verbal communication, technical writing, project management tools and word processing skills.
• Diverse experience in leading project teams related to the commissioning and qualification of clean/dirty utilities, HVAC, facility systems, process support systems, and process equipment.
• Willing and able to travel as necessary for project requirements to include but not be limited to: Factory Acceptance Testing, project installation and start-up activities, client meetings, company sponsored meetings, etc.
• Ability to be a part of the field execution team.
• Proficiency with Microsoft Office including Word, Excel, and PowerPoint. Microsoft Project and Visio a plus.

Education
• BS Degree in Engineering/ STEM discipline or related technical degree.

Equal Employment Opportunity  

ValSource is an equal opportunity employer. We provide equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, genetic information, military status, or veteran status. We are committed to creating an inclusive environment for all employees.  

 Authorization  

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States up hiring/onboarding.  ValSource participates in E-Verify and will provide the Federal Government with your Form I-9 information to confirm that you are authorized to work in the United States.   

Other Information  

These career opportunities are full-time positions with ValSource. Applicants must be authorized to work in the United States on a full-time basis without the need for current or future sponsorship. We do not accept unsolicited applications or resumes from third-party staffing agencies, independent contractors, or recruiting vendors. 

About ValSource 

ValSource is one of the largest independent validation services companies in North America with over 350 full-time Engineering, Commissioning, Qualification and Validation employees. ValSource returns validation to a scientific event which helps companies design, perform and better control manufacturing processes throughout all stages of the operations life cycle. Full-time employees are offered a competitive compensation package that also includes full benefits (100% employer paid medical, dental, vision, short- and long-term disability), 401k, paid time off (holidays and vacation), continuous training and development, Employee Stock Ownership Plan (ESOP), discretionary bonus, etc.