Project Manager / Sr. Project Manager

Responsibilities

• 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.

Qualifications

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

Benefits

• 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.

Pay

Competitive compensation package.

Schedule

Full-time position.

Company Information

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.