Project Manager, GMP

1 week ago

Mission Viejo, California, United States BENEV Company Inc Full time
About The Role

BENEV is seeking a highly skilled Project Manager to play a critical role in managing projects related to the growth and development of GMP facilities and systems. This role requires strong leadership, organizational, and communication skills to ensure projects are completed on time, within scope, and on budget.

Key Responsibilities
  • Develop and maintain comprehensive project plans, including scope, timelines, resources, and budgets.
  • Lead project teams to meet quality and compliance standards, ensuring timely execution.
  • Build and maintain strong relationships with internal and external stakeholders, ensuring clear communication, alignment on project goals, and effective issue resolution.
  • Manage project resources, including personnel, budget, and technology, to support project success.
  • Ensure adherence to quality standards, best practices, and compliance.
  • Maintain project documentation, including status reports, project charters, and other relevant documents, and provide regular updates to senior leadership and stakeholders.
  • Implement change management strategies and communicate project changes as needed.
  • Coordinate with engineering, facilities, and quality teams to ensure the timely installation, commissioning, and qualification of equipment and systems.
  • Oversee the validation process for critical systems, including HVAC, water systems, and production equipment to ensure all systems are compliant with GMP regulations and company SOP's.
  • Work closely with internal stakeholders, including Quality Assurance, Manufacturing, and Engineering teams, to ensure seamless project execution and compliance with GMP standards.
  • Identify potential risks associated with GMP facilities and systems projects and develop mitigation strategies to address these risks proactively.
  • Maintain detailed project documentation, including validation protocols, change controls, and status reports, ensuring all documentation meets regulatory and company requirements.
  • Drive continuous improvement initiatives related to GMP facilities and systems, identifying opportunities for process optimization.
  • Serve as the primary point of contact for all GMP facility and systems projects, providing regular updates to senior management and other stakeholders.
Requirements
  • 5+ years of project management experience within a GMP-regulated environment.
  • Strong knowledge of GMP regulations, particularly in facility and system validation.
  • Experience partnering with quality systems teams/function.
  • Proven experience managing complex, cross-functional projects.
  • Excellent communication, organizational, and problem-solving skills.
  • Ability to work independently and manage multiple priorities in a fast-paced environment.
Preferred Skills
  • Knowledge of regulatory requirements for system validation (e.g., FDA, EMA).
  • Familiarity with Lean Six Sigma or other process improvement methodologies.
  • Project Management Certifications (e.g., PMP).
Work Environment and Physical Demands

This position works in a typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. This is largely a sedentary role; persons holding office positions are generally subject to inside environmental conditions having the lighting, temperature, and noise of an open floor-plan office environment. Regularly operate a computer and other office equipment. Regularly communicate with others in person, over the phone, and electronically. Must be able to move and/or carry objects weighing up to 10 lbs.

  • Project Manager

    4 weeks ago

    Mission Viejo, California, United States BENEV Company Inc Full time

    About the RoleWe are seeking a highly skilled Project Manager to join our team at BENEV Company Inc. as a key member of our GMP facilities and systems team. As a Project Manager, you will play a critical role in managing projects related to the growth and development of GMP facilities and systems.This role requires strong leadership, organizational, and...

  • Project Manager

    2 weeks ago

    Mission Viejo, California, United States APSI Construction Management Full time

    Project Engineer Job DescriptionAPSI Construction Management is seeking a skilled Project Engineer to join our team. As a Project Engineer, you will play a crucial role in the success of our projects, working closely with our on-site Project Managers to ensure timely completion and high-quality results.Key Responsibilities:Assist on-site Project Managers in...

  • Project Manager

    1 week ago

    Mission Viejo, California, United States CyberCoders Full time

    Job Title: Project ManagerWe are a leading Civil Engineering Company seeking an experienced and motivated Civil Engineer or Structural Engineer to advance their career as our full-time Project Manager.Responsibilities:Lead a team of Civil Engineers or Structural Engineers and Drafters to successfully complete projects.Produce structural analysis, designs,...

  • Structural Project Manager

    1 week ago

    Mission Viejo, California, United States Jobot Full time

    About JobotJobot is a cutting-edge firm that specializes in engineering and project management. We are passionate about delivering innovative solutions and exceptional results.Job DetailsWe are seeking a highly skilled and experienced Assistant Structural Project Manager to join our team. As a key member of our project management team, you will be...

  • Project Documentation Manager

    5 days ago

    Mission Viejo, California, United States oilandgas Full time

    About the RoleWe are seeking a highly skilled Project Documentation Manager to join our team at Schneider. As a key member of our project team, you will be responsible for managing project documentation from start to finish, ensuring that all documentation is accurate, complete, and delivered on time.Key ResponsibilitiesManage project documentation from...

  • Survey Project Manager

    6 days ago

    Mission Viejo, California, United States Randstad Full time

    Job Title: Survey Project ManagerWe are seeking a highly skilled Survey Project Manager to join our team. As a Survey Project Manager, you will be responsible for overseeing and reporting on budgets and resource utilization, as well as being the key point of contact between our company and clients.Key Responsibilities:Manage land survey projects from start...

  • Survey Project Manager

    6 days ago

    Mission Viejo, California, United States Randstad Full time

    Job Title: Survey Project ManagerWe are seeking a highly skilled Survey Project Manager to join our team. As a Survey Project Manager, you will be responsible for overseeing and reporting on budgets and resource utilization, as well as being the key point of contact between our company and clients.Key Responsibilities:Manage land survey projects from start...

  • Project Manager

    2 weeks ago

    Mission Viejo, California, United States 4 S.T.E.L. Engineering, Inc. Full time

    {"h1": "Project Engineer Position at 4 S.T.E.L. Engineering, Inc.", "p": "We are seeking a highly skilled Project Engineer to join our team at 4 S.T.E.L. Engineering, Inc. in Anaheim, CA. As a Project Engineer, you will be responsible for designing and developing structural engineering projects, collaborating with a team of professionals, and ensuring client...

  • Structural Engineering Project Manager

    4 weeks ago

    Mission Viejo, California, United States Jobot Full time

    About the RoleWe are seeking a highly skilled and experienced Project Manager for our Structural Engineering team. As a Project Manager, you will be responsible for leading a team of Civil Engineers and Structural Engineers to successfully complete projects.Key ResponsibilitiesLead a team of Civil Engineers and Structural Engineers to complete projects on...

  • Structural Engineering Project Manager

    2 weeks ago

    Mission Viejo, California, United States 4 S.T.E.L. Engineering, Inc. Full time

    Job Title: Assistant Project Manager - Professional EngineerAbout the Role:4 S.T.E.L. Engineering, Inc. is seeking a licensed Civil Engineer or Structural Engineer to fill the position of Assistant Project Manager - Professional Engineer. As a key member of our team, you will oversee various structural engineering projects, ensuring timely completion and...

  • Senior Project Manager

    2 weeks ago

    Mission Viejo, California, United States Starts Align LLC Full time

    Job DescriptionWe are seeking a highly experienced Senior Project Manager to join our team in the Texas division. The ideal candidate will have a strong background in heavy civil construction, with a proven track record of managing large-scale projects. The Senior Project Manager will be responsible for overseeing the planning, execution, and administration...

  • Project Director

    5 days ago

    Mission Viejo, California, United States Clayco Full time

    About Us:Clayco is a leading provider of integrated real estate development, architecture, engineering, and construction services. With a strong focus on delivering high-quality solutions, the company has established itself as a trusted partner for clients across North America.Why Choose Clayco?Clayco has been recognized as one of the top contractors in the...

  • Project Director

    2 weeks ago

    Mission Viejo, California, United States Clayco Full time

    About Us:Clayco is a leading provider of integrated real estate development, architecture, engineering, and construction services. With a strong focus on delivering high-quality solutions, the company has established itself as a trusted partner for clients across North America.Why Choose Clayco?Clayco has been recognized as one of the top contractors in the...

  • Structural Engineering Project Manager

    1 month ago

    Mission Viejo, California, United States 4 S.T.E.L. Engineering, Inc. Full time

    About 4 S.T.E.L. Engineering, Inc.We are a leading provider of structural engineering solutions, serving a wide range of industries including commercial, industrial, institutional, residential, and renewable energy. Our team of experienced professionals brings decades of combined expertise to each project, utilizing innovative skills and engineering know-how...

  • Construction Project Director

    2 weeks ago

    Mission Viejo, California, United States The Judge Group Full time

    The ideal candidate will oversee projects from inception to completion. You will work closely with senior management and serve as the primary point of contact for clients.We have multiple openings for Estimators, Superintendents, and Project Executives, so feel free to apply if you're interested in those roles.Key ResponsibilitiesManage all stages of the...

  • Structural Engineering Project Lead

    4 weeks ago

    Mission Viejo, California, United States Jobot Full time

    About UsOur Engineering Firm specializes in providing structural design, engineering, and calculations for a wide variety of construction projects. We work on a variety of wood, steel, concrete, masonry, cold form steel, and aluminum projects. Our team is passionate about what we do and always strives to be a collaborative and innovative firm. Our talented...

  • Construction Project Manager

    4 weeks ago

    Mission Viejo, California, United States pulteGroup Full time

    Job SummaryThis position is responsible for overseeing the construction process, ensuring timely completion, safety, and quality standards are met.Key ResponsibilitiesValidate schedule progression and adherence.Collaborate with the team to improve planning activities, including vendor coaching and performance feedback.Manage customer experience throughout...

  • Wealth Management Professional

    2 weeks ago

    Mission Viejo, California, United States Moneta Corporation Full time

    Unlock Your Potential in Wealth ManagementAt Moneta Corporation, we're seeking a talented and ambitious individual to join our wealth management team as a Wealth Management Intern. As a key member of our team, you'll have the opportunity to gain hands-on experience in financial planning, investment strategies, and client relationship management.Key...

  • Wealth Management Professional

    3 weeks ago

    Mission Viejo, California, United States Moneta Corporation Full time

    Unlock Your Potential in Wealth ManagementAt Moneta Corporation, we're dedicated to providing exceptional wealth management services to our clients. As a Wealth Management Intern, you'll have the opportunity to work alongside our experienced team and gain hands-on experience in financial planning, investment strategies, and client relationship management.Key...

  • Implementation Manager, Automation Solutions

    4 weeks ago

    Mission Viejo, California, United States Kansas Employer Full time

    Job SummaryThis position will assess client business systems and effectively integrate applicable hardware and software solutions, including system implementations, upgrades, custom development projects, and coordinating new contract set ups with the ScriptPro Robotic System.Key ResponsibilitiesWork with customers to gather, manage, and prioritize...