Quality Engineer

The Fountain Group LLC

Frederick, MD

JOB DETAILS
SALARY
SKILLS
Best Practices, Biotech and Pharmaceutical, Calibration, Computerized Maintenance Management System (CMMS), Current Good Manufacturing Practice (cGMP), Establish Priorities, FDA (Food and Drug Administration), Gene Therapy, IBM Maximo Asset Management, Manufacturing, Metrics, Product Development, Property Management, Quality Control, Quality Engineering, Quality Management, Risk Management, Secondary School, Supply Chain
LOCATION
Frederick, MD
POSTED
2 days ago
Pay: $36.28/Hour

Duration: 1 year

Location: Frederick, MD (Onite 5 days a week)

Responsibilities:
  • Provide Quality oversight and guidance for all cGMP Work Orders performed on critical equipment, facility and utilities necessary for commercial and clinical production.
  • Provide Quality oversight and resolution guidance for all alarms generated by our Equipment Monitoring System (EMS) which actively monitors our critical equipment, facility, and utilities necessary for commercial and clinical production.
  • Demonstrate intimate working knowledge of pharmaceutical relevant standards, principles and best practices.
  • Collaborate with project teams and necessary departments (e.g. manufacturing, engineering, product development, quality control, supplier quality, supply chain) in the execution of CQV and CSV, as needed.
  • Track, review and report metric information as necessary.
  • Support Quality Engineering functions as necessary, including oversight of validation activities and quality risk management.
 
Basic Qualifications:
  • Master’s Degree OR Bachelor’s Degree and 2+ years’ experience in a pharmaceutical or FDA regulated environment OR AA Degree and 4+ years’ experience in a pharmaceutical or FDA regulated environment OR High School Degree and 5+ years’ experience in a pharmaceutical or FDA regulated environment.
 
Preferred Qualifications:
  • Familiarity with cGMP maintenance planning, execution and closure through a Computerized Maintenance Management System.
  • Familiarity with cGMP calibration planning, execution, and closure through CMMS
  • Experience in building management systems (e.g. Siemens Desigo) is a plus.
  • Experience in CMMS (e.g. BMRAM and/or Maximo) is a plus.
  • Must be able to prioritize, manage and follow-up on numerous projects and activities
  • Cell and Gene Therapy experience is a plus
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About the Company

T

The Fountain Group LLC

The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.

COMPANY SIZE
500 to 999 employees
INDUSTRY
Staffing/Employment Agencies
WEBSITE
https://www.thefountaingroup.com/