Project Manager - Coordinator (3156AE)

Verista’s 700 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. Whether it’s compliance, quality management, verification, validation, automation, IT infrastructure, data analysis, manufacturing, or packaging, we deliver solutions that are right the first time.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Project Manager Responsibilities:

• Provide overall coordination of complex site improvement projects at plant, supporting multiple facility engineers across a range of business disciplines.
• Author and manage execution of commissioning protocols for GMP direct impact water systems and Controlled Temperature Environments.
• Held responsible for concept planning, technical design, and schedule administration for concurrent diverse proposals.
• Maintained proficiency in bid compilation and selection, procurement, resource and process management.
• Establish and lead team governing all aspects of plant and administrative functions, from fundamental development phase through deployment and execution.
• Implement and maintained budget and agenda analyses, while acting as the main point of contact for the project team.
• Directed vendor access, activities, timelines, and disbursements.
• Oversaw plant and project documentation amendments for the engineering change management system.
• Managing internal project scope of work, budget, timeline, and change orders.
• Taking responsibility for materials planning, budget development and cost control for assigned projects.
• Specifying and procuring equipment and resources needed on the project(s).
• Managing and performing the start-up, commissioning, and validation of manufacturing and packaging equipment and associated support systems.
• Leading the CQV (Commissioning, Qualification and Verification) processes for protocol development and execution.
• Leading internal and/or client management activities for assigned projects:
• Identifying and addressing complex technical issues and resourcing.
• Supporting team members; acting as the liaison to the client for discussing changes in scope of work, timeline, or budget.
• Providing frequent/clear/concise project updates to internal/external customers (bi-monthly minimum).•Utilizing troubleshooting/problem solving skills to drive solutions to equipment/process issues, including FMEA and root cause analysis methodology.
• Providing technical expertise on equipment/processes in manufacturing and packaging areas.
• Leading the team to complete equipment design and specification, vendor bids, vendor selection, and equipment purchasing.
• Interfacing with vendors, when necessary, to ensure vendors will deliver parts, materials, components and equipment on-time, on-budget and to technical specifications.
• Developing and creating technical validation and engineering.
• Developing, writing, and executing engineering studies.
• Developing SOPs/Guidance Documents for project equipment and processes which are highly complex and require advanced engineering to develop.
• Performing Quality investigations (CAPA, Event, Periodic Reviews).
• Maintaining, updating, and communicating project status via dashboards or other customer preferred method
• Executing projects to internal or customer standards, while also making recommendations to update standards to meet best practices.

Requirements

You will have:

• This position requires a minimum of a Bachelor’s degree in an Engineering or Scientific degree.
• CQV Validation and Engineering experience
• Industrial/Manufacturing engineering experience involving compliance, procedures, and process improvements in highly regulated industry involving GMP, FDA, OSHA, and Change Control
• Troubleshooting experience with automated equipment (PLCs, HMIs, PC based controls), laboratory and/or enterprise software systems
• Proficiency in understanding electrical, mechanical, piping, instrumentation (P&ID), and facility drawings
• Experience with