ATL01-013024 Project Manager/Leader - GA - Validation & Engineering Group

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Project Manager/Leader
• Location: Georgia, USA

Responsibilities:

1. Develop the project C&Q master plans, identify task lists and project timelines in line with the objectives and goals of the projects, and propose sub-plans to facilitate the C&Q process, and eliminate roadblocks.
2. Interface with the project teams to develop the overall C&Q phase project plan and schedule and integrating with the project overall plan. C&Q planned activities includes risk assessment, design reviews, test matrices, FATs, SATs, commissioning, installation, operational and performance verification for all systems as applicable.
3. Lead the C&Q cost and schedule control process.
4. Work closely with Systems’ Owners, SMEs, Automation/IT, Quality, and Technology Leads to ensure readiness for facility, process and clean utilities verification.
5. Managing verification phase improvement (lessons learned, deviation management and resolution, etc.).
6. Ensuring C&Q program alignment with client corporate standards along with engineering best practices.
7. Responsible for project C&Q documentation development and management and quality of the turnover documentation library.
8. Responsible for the C&Q staffing plan, hiring, management, mentoring and development.
9. Management for other C&Q activities:
   • Determine the C&Q tasks by categorizing project system list.
   • Review & approve C&Q documentation.
   • Manage all required training.
   • Regular meeting with C&Q team, regular C&Q status update to project management and stakeholders.
   • Regular meetings, updates, and progress reports and reviews with the Client Site Lead (weekly reports, monthly C&Q metrics reporting, periodical training, and quarterly C&Q progress reviews)
   • Ensure client EHS&S guidelines are met during C&Q execution.
   • Manage and close major deviations (punch list and exceptions list) in time before next phase.
   • Develops the Qualification Summary Reports, reviews and comments on the assembly and the handover of qualified systems TOPs and secures acceptance and release to the systems’ owner.

Qualifications:

1. Technical degree is a must.
2. Minimum 5 years of experience in C&Q of pharmaceutical and /or Medical Device environment is a must (project-dependent).
3. Experience with current commissioning and qualification methods, including ISPE, ICH, and Risk-Managed approach.
4. Knowledge of local regulatory requirements relevant to pharmaceutical and/or medical devices facilities.
5. Excellent problem solving and troubleshooting abilities.
6. High level of familiarity with Excel, Word, Access, and Microsoft Project.
7. Strong time management and project management skills.
8. Ability to work in a fast-paced environment.
9. Self-starter with strong interpersonal, organizational, and technical skills.
10. Capability to work both independently and in a team environment.
11. Strong analytical and communications skills are required.
12. Excellent written and verbal presentation skills to support interactions with all levels of stakeholders and peers as required.
13. Ability to forge consensus with conflict resolution capability.
14. Must be able to establish strong working relationships with stakeholders (project management, quality, operation, system owner and tech. transfer) to ensure high quality deliverables meeting cGMP and site quality requirements.