Project Manager, CQV - Pharmatech Associates, Inc.

We are looking for a Project Manager, Validation/CQV to join our consulting team for a contract role located in Wilmington, NC

• Directly responsible for the successful delivery of commissioning and compliance projects to clients.
• Leads multiple concurrent small, mid-sized, or large projects.
• Runs meetings, communicates status and project issues with client representative(s), and facilitates general project coordination activities.
• Ensures all work meets budget requirements and quality standards.
• Program 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.
• Candidate 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
• Responsible for developing project scope statements, estimates and proposals.

KEY ACTIVITIES AND RESPONSIBILITIES

• Develop project schedules, deliverable tracking reports, scope adjustment notices
• Support, train, mentor, and provide guidance to commissioning and validation specialists/engineers and project leaders in the delivery of CQV services for assigned projects
• Assist or take lead in proposal development including scope definition, attend bid meetings, development of hours and cost budgets and proposal presentations
• Lead the team in generating and executing CQV protocols using Good Documentation Practices (GDPs)
• Lead execution of CQV testing with support from contractors, engineering and operations
• Stay current (training, reading, professional organization involvement) with industry trends and current CQV methodologies.
• This position is client facing with an emphasis on ensuring CQV project deliverables meet schedule, cost, scope, quality, and safety.
• Apply engineering knowledge of, and experience with, manufacturing equipment, process equipment, HVAC, utilities, instrumentation, controls, and automation to support assorted projects and clients
• This position will have travel as required by the assigned project.
• Position may be assigned to client site for an extended period of time.
• Overnight travel or staying in the city of projects location is possible depending on assignment.
• Must be self-sufficient and effectively work with limited to no supervision.
• Make recommendations for possible project and procedural improvements.

QUALIFICATIONS

• Bachelor’s degree in a life science discipline plus a minimum of 10 years of experience in Pharmaceutical, Biotech or Medical Device industries
• Experience in writing and execution of IQ, OQ, and PQ forms/protocols for GMP Utilities, Equipment and Systems is required
• Strong knowledge of US FDA (21 CFR 210, 211, 810) regulations
• General exposure and experience in a GMP/Validation discipline with knowledge and understanding of pharmaceutical Design/Build/Commission/Validate processes and how they relate to FDA regulatory requirements and cGMP regulations is required.
• Experience with Cleaning, Process, Computer System, Methods, and other validation activities and processes is preferred
• Strong working knowledge of commissioning, qualification and validation deliverables, team building and client relationship building is required
• Ability to tracking progress according to schedules and cost estimates is required
• Flexibility and willingness to travel and work at various clients locations is required
• Project Management Professional (PMP) certification or Professional Engineer (PE) license desirable.
• Ability to write and manage others in the preparation of CQV documents following established standards and templates, including but not limited to the following:
• CQV Master Plans
• Commissioning Test Plans
• CQV Protocols and Summary Reports
• Standard Operating Procedures
• Impact Assessments
• Specifications (URS/FRS/DDS)FATS/SATs
• Able to perform and manage others during site activities including, but not limited to, the following:
• Attend FATs and SATs as a representative of our clients.
• Execution of commissioning forms and witnessing of vendor start-up and testing.
• Execution of CQV protocols.
• Walkdown and verification of system drawings
• Perform and manage staff in compiling data packages and prepare reports for completed CQV activities.
• Audit project deliverables to assure compliance with established standards.

Pharmatech Associates, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.