QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA
Responsibilities:
- Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment.
- Work with Manufacturing to develop user requirements for capital projects
- Develop project schedule of installation and qualification activities.
- Work directly with construction and C&Q contractors to deliver project deliverables.
- Reviewing and analyzing cost estimates, bids, change orders, invoices, progress measures etc.
- Budgeting, tracking and controlling Amgen costs as well as engineer/contractor costs
- Administer the implementation and closeout of projects
- Communicating and reporting to leadership on project matters.
- Functions (Duties/Accountabilities Reviewing and analyzing engineer/contractor bids.
- Monitoring and evaluating engineer/contractors' physical progress.
- Addressing progress and delay claims from contractors.
- Preparing monthly project status reports for senior management. Developing and monitoring project schedules.
Qualifications:
- Bachelor's degree in engineering (Mechanical or Chemical Engineering)
- 5 years of Engineering experience
- Must have strong technical experience working on medium size projects supporting industrial process equipment and biotechnology manufacturing facilities including C&Q & start up activities for Manufacturing facilities.
- Skills in leadership, communication, and conflict resolution.
- Understanding of the technical and business aspects of projects in order to provide solutions to problems that require ingenuity and creativity.
- Credibility and presence within the organization when topics related to projects are being addressed.
- Ability to interface with technical, scientific and management internal user groups.
- Preferred experience working directly for a biotechnology or pharmaceutical industry a project engineering environment.
- Availability for administrative shift
Top Skills
What We Do
The Quality Consulting Group is a pharmaceutical, biotechnology, food and medical device specialty consultant that supports the manufacturing industry; services are provided in multiple areas including: Regulatory Compliance, Quality Operations, Validation, Manufacturing, Training and Technical Support. Starting, as individual services provider since 2002, Quality Consulting Group has supported clients implementing the latest standards such as Validation Guidance, ICH Guidelines, and Process Excellence and Risk Management tools.
Quality Consulting Group has provided expertise in such areas as: business, operational, quality, regulatory and manufacturing strategies; organizational structures; management controls; manufacturing and quality systems methodologies and practices; compliance programs; and accuracy reviews; FDA, EMEA and other regulatory matter
