Intrexon Germantown , MD 20874
DUTIES AND RESPONSIBILITIES:
Draft and perform or coordinate IOQ protocols for GMP equipment.
Coordinate and perform calibration/PM/repair activities for GMP equipment.
Review documentation associated with calibration/PM for compliance with requirements.
Direct calibration activities of outside calibration vendors.
Coordinate shipping of instruments for outside calibration.
Maintain equipment monitoring system (ElPro), including:
Coordinating and reviewing calibration/PM of system hardware (sensors)
Preparation of trending reports on equipment performance
Maintain Master Equipment Files for GMP equipment.
Draft and review Standard Operating Procedures for use, cleaning, and maintenance of GMP equipment, as necessary.
Participate in cleaning of GMP equipment.
Serve in an on-call capacity to assure that any equipment alarms for the GMP suite and equipment in the QC lab as priority items, and secondarily for equipment in the Precigen research laboratories, are appropriately attended to.
EDUCATION AND EXPERIENCE:
Associates Degree and a minimum of 2 years' experience in a biotechnology GMP environment.
Applicants with a high school diploma and 4 years' experience in a biotechnology GMP environment will be considered.
Exceptional organizational skills and attention to detail.
Good computer skills, including calibration management software (CalMan type or equivalent) and instrument monitoring software (ElPro type or equivalent).
DESIRED KEY COMPETENCIES:
Ability to understand and execute on the company's mission and values.
Maintain a high degree of ethical standard and trustworthiness.
Capable of fostering change in an organization.
Deals with conflict in a direct, positive manner.
Ability to think and adapt to a rapidly changing environment and demands.
Able to reach rational conclusions through complex processing of information.
Fosters innovation through creative solutions.
Effective organization and implementation of group projects.
Maintain a high degree of accuracy and attention to detail.
Energized by accomplishments and excellence in the workplace.
Capable of high performance in independent work as well as in team setting.