Project Manager

Job Summary:

• We seek a Project Manager that will work closely with our sales development team and customers to manage custom single-use hardware systems.
• The candidate must be well organized and have excellent communication skills.
• This position will involve developing quotations and will be responsible for initiating, managing, organizing, executing, and closing custom hardware projects.
• The candidate will be the primary interface with the sales and the customer.

Duties and Responsibilities:

• Responsible for the creation/modification of P&IDs, specifications, technical exceptions, schedules and project cost based on the review and interpretation of customer’s request for quote/proposal and user requirement documentation.
• You will be the client's primary contact throughout the project.
• Manage the project from project initiation to completion.
• Manage schedules and costs by keeping spending within project limits and ensure ***’s quality standards are met.
• Able to assess the impacts on cost and schedules due to requests for modifications made by clients and seek agreement to ensure such requests are properly met.
• Development factory release test.
• Facilitate factory acceptance testing at our supplier’s site.
• You will primarily support US and LATAM sales team with potential support to EU and Asia sales teams.
• Provide weekly project status reports as required.
• Participate/support in root cause investigations and corrective action activities, if needed.

Required Education and Experience:

• Bio pharma experience a huge plus.
• Minimum of a bachelor’s degree in engineering, Prefer Mechanical or Electromechanical.
• Minimum 5 years industry experience.
• Work experience within the pharmaceutical industry preferred.
• Project Management experience.
• Experience in customer relationships.

Preferred Knowledge & Skills:

• Knowledge in single-use systems – Mixers, Bins, & Bioreactors a plus.
• Knowledge of cGMP FDA, GAMP, ASME-BPE, CE, and UL requirements / guidelines.
• Ability to work in a global / multicultural team environment.
• Team player with the ability to unite a team around a project.
• Strong verbal and written communication skills.
• Strong computer skills with MS office applications including Word, PowerPoint, Excel; Projects, SharePoint, and AutoCad.
• Travel required for FATs.