Project Manager

Project Manager

ValSource is currently looking to identify experienced and technically skilled leaders with Project Lead and Project Management experience to support a variety of exciting projects with our clients in the pharmaceutical and biotech and related GMP manufacturing industries throughout each of our regions in the US.

The Commissioning, Qualification & Validation (CQV) Project Manager will interface with our clients and be responsible for preparing and executing commissioning, qualification, and validation protocols and documents for a variety of utilities, facilities, and process equipment used in the FDA regulated pharmaceutical and biotech manufacturing industries.

Project Manager is responsible for managing and executing validation projects directly at client sites, ensuring that pharmaceutical manufacturing processes and systems meet regulatory and quality standards. This role involves extensive travel to various client locations, overseeing on-site validation and equipment qualification activities, and ensuring compliance with FDA, GMP, and other regulatory requirements.

Responsibilities
On-Site Project Management :

• 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.
• Develop and maintain project schedules, ensuring timely completion of all validation activities.
• Coordinate on-site resources, including internal teams, contractors, and client personnel
• Project Manager is responsible for the overall project execution and project deliverables related to Commissioning, Qualification and Validation of pharmaceutical or biotech manufacturing equipment and processes in the manufacturing field. Also responsible for activities related to the start-up, commissioning, qualification, validation of Pharmaceutical and Biotech GMP manufacturing facility systems and equipment.

Validation Execution :

• Field Execute and oversee on-site validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Troubleshoot and resolve issues that arise during validation activities, providing technical expertise and guidance.
• Ensure all validation work is performed in accordance with regulatory guidelines, client requirements, and company SOPs.
• Field Verifications and system walkdowns to confirm systems meet design and client specifications.

Regulatory Compliance :

• Ensure compliance with all relevant regulatory standards, including FDA, GMP, and ICH guidelines, during on-site validation.
• Prepare for and support client regulatory inspections and audits as needed.
• Stay current with industry regulations and best practices to ensure compliance.

Other Responsibilities:

• The Project Manager will help lead business development efforts in the region as it relates to engaging with new clients in the life sciences sector, and expanding our engagements with existing clients
• The Project Manager will be responsible for developing project scope statements, estimates and proposals.

Requirements

• Minimum of 7 years’ experience with increasing responsibility in validation/quality service and project management of life sciences, biotech or other FDA regulated projects.
• Experience with project management, good documentation practices, cGMP, & FDA validation methods and systems, ability to read engineering documents, set priorities, and work on multiple projects simultaneously.
• Strong understanding of EPCMV, Quality by Design and risk-and science-based approaches for compliance are desired.
• Experience with system and process risk assessments; including FMEA, HAZOP and Fault Tree Analysis 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 utilities, facility systems, process support systems, bioprocess manufacturing systems, packaging equipment, and process and cleaning validation is desirable.
• Working knowledge of process automation and computer system validation concepts, GAMP methodologies, 21 CFR Part 11 compliance and latest industry expectations for data integrity.
• Project Management experience in managing scope, cost, schedule, quality, and risk is required.
• Willing and able to travel as necessary for project requirements to include but not be limited to: project installation and start-up activities, client meetings, company sponsored meetings, trainings.
• Proficiency with Microsoft office including Word, Excel, and PowerPoint. Experience with Microsoft Project and Visio a plus.
• Ability to work in various pharmaceutical or biotech manufacturing environments including:

1. Walking, bending, reaching, standing, sitting, measuring, verifying, lifting (up to 25lbs)
2. Working at heights including ladders or platforms to complete equipment and related utility systems verifications.
3. Working in pharma/biotech environments with potential exposure to hazardous chemicals used in the manufacturing or cleaning and sterilization process, including work around pressurized vessels and/or corrosive chemicals.
4. Travel to equipment vendors for Factory Acceptance Testing (FAT) which includes vessel spray coverage testing.
5. Working on a computer to draft protocols, analyze data and write reports.

Education
BS Degree in Engineering / STEM discipline or related technical degree and combined relevant industry experience.

Other information

This is a full-time position with ValSource. As such, we are not considering applications from employment agencies, independent contractors, or third-party vendors.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

Benefits

Benefits of full-time employment with ValSource will include:

• Paid Time Off (PTO) and Holidays
• Medical / Dental / Vision Insurance - premiums 100% paid by ValSource for Employee to Family level coverage
• Basic Life / Short- and Long-Term Disability / Voluntary Life / AD&D Insurance coverages
• ValSource 401(k) Plan
• ValSource Employee Stock Ownership Plan (ESOP)
• Paid Maternity / Parental Leave
• Medical Leave Pay
• Tuition Reimbursement / Continuing Education
• Annual Performance Bonus Compensation
• About ValSource

About ValSource

ValSource is one of the largest independent Validation Services Company in North America with over 350 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 (medical, dental, vision, short- and long-term disability), 401k, paid time off (holidays and vacation), continuous training and development, Employee Stock Ownership Plan, discretionary bonus, etc.

Equal Employment Opportunity

ValSource provides 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, and veteran status.