AM Technical Solutions- Who Are We:
AM Technical Solutions (AM), founded in 1994, is a proven and licensed architecture, engineering, and construction firm bringing innovative solutions to the Biopharma industry to help in the fight to save lives. Our knowledge and expertise in high-tech spaces combined with our culture-first mentality allows our team to deliver the entire scope of work for high-tech construction projects on schedule, on budget, and at the level of quality required by customers. AM Life Science being an integrated part of AM Technical Solutions brings new energy and ideas to an ever-changing industry. Our team is comprised of motivated, intelligent, capable and qualified individuals who design, execute and manage projects and programs that implement risk-based approaches utilizing scientific data and justifications to align with the regulatory and industry standards. AM Life Science takes pride in our accuracy, efficiency, and integrity, which translates into cost and time savings for our Clients.
Responsible for assisting PM in all aspects of completing the design, construction, and start-up of the facility. This position will allow for fluid interaction between multiple departments, including Manufacturing, Facilities, Quality Assurance, Validation, Regulatory, and site Engineering to facilitate closure of task items and completion of projects. May be involved in vendor management, equipment, and facility design, including Conceptual Design, Basis of Design, and Detailed Design, including equipment specification, procurement, construction, and commissioning of process equipment for cGMP production facilities. May be involved in technology transfers, including feasibility studies, facility fit assessment, generation of user requirements, process description, change control ownership, commissioning test plans, training of Site Engineers and Manufacturing personnel, as well as startup, commissioning, validation, and operational support.
Direct Involvement Opportunities:
Support Responsibilities may include:
- Review of Submittals for equipment and trades
- Design/Value Engineering Reviews
- ETOP/CTOP review
- Commissioning support
- Writing/reviewing commissioning/validation documentation
- Equipment start up
Familiarity with the following beneficial:
- WFI (membrane system)
- Clean Steam Generator
Qualifications, Skills, And Experience:
- Bachelor’s degree or equivalent in Engineering, Science, or related discipline
- 5+ years of experience working in a GMP manufacturing facilities role.
- Ability to effectively communicate with all levels within the organization
- Ability to build collaborative relationships with colleagues and clients
- Demonstrated effectiveness in a dynamic, fast-paced, and ever-changing environment.
- Able to deal with pressure, take on challenging projects, manage competing priorities, and anticipate problems in advance