ATL01-013024 Project Manager/Leader
4 weeks ago
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:
- 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.
- 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.
- Lead the C&Q cost and schedule control process.
- Work closely with Systems’ Owners, SMEs, Automation/IT, Quality, and Technology Leads to ensure readiness for facility, process and clean utilities verification.
- Managing verification phase improvement (lessons learned, deviation management and resolution, etc.).
- Ensuring C&Q program alignment with client corporate standards along with engineering best practices.
- Responsible for project C&Q documentation development and management and quality of the turnover documentation library.
- Responsible for the C&Q staffing plan, hiring, management, mentoring and development.
- 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:
- Technical degree is a must.
- Minimum 5 years of experience in C&Q of pharmaceutical and /or Medical Device environment is a must (project-dependent).
- Experience with current commissioning and qualification methods, including ISPE, ICH, and Risk-Managed approach.
- Knowledge of local regulatory requirements relevant to pharmaceutical and/or medical devices facilities.
- Excellent problem solving and troubleshooting abilities.
- High level of familiarity with Excel, Word, Access, and Microsoft Project.
- Strong time management and project management skills.
- Ability to work in a fast-paced environment.
- Self-starter with strong interpersonal, organizational, and technical skills.
- Capability to work both independently and in a team environment.
- Strong analytical and communications skills are required.
- Excellent written and verbal presentation skills to support interactions with all levels of stakeholders and peers as required.
- Ability to forge consensus with conflict resolution capability.
- 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.
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