Program Coordinator Iii - Aseptic Processing & Cleanroom Management

Job Title: Program Coordinator III

Location: Houston TX 77047

Duration: 6 Months

Job Type: Contract

Work Type: Onsite

Shift Timings : M-F 8-5 Shift

JOB DESCRIPTION:

• The role of the Manufacturing Suite Point of Contact (POC) is to act as an aseptic champion driving cleanroom management, on-the-floor observations, and leading aseptic improvement projects for manufacturing operations.
• Outside of daily requests, the POC will own the suite-specific planning schedule, POC walk-throughs performed on a regular basis, and maintain graded and production areas audit-ready.
• On a daily basis, the POC will be responsible for the fulfillment of immediate requests from the MFG support departments including, but not limited to, work order initiation for calibration and facilities/suite maintenance, Out of Service (OOS) tag placement, and removal.
• To further support the daily operation of the suite, the POC will assist MFG technicians by providing guidance on aseptic behaviors on the production floor.

Key responsibilities:

• Work cross-functionally with scheduling to identify and plan for any non-routine suite and equipment windows needed (Calibration/Maintenance)
• Coordinate placement and removal of quality tag-outs
• Perform other duties as assigned.
• Administrative tasks –attending shift exchange and daily production meetings, sending/receiving emails, training, etc.
• Champion holistic approaches to sterility assurance through a combination of robust aseptic practices and continuous improvement.
• Own and manage change controls, CAPA and support with minor track and trend deviations
• Lead by example to embed a strong quality and sterility assurance culture within manufacturing teams and across support functions.
• Ensure substantial ‘on the floor’ presence, providing real-time education, feedback and
• Coaching to manufacturing teams that establishes, improves, and maintains good aseptic behaviors and cleanroom standards.
• Create, update, and own changes on standard operating procedures used by CT manufacturing
• Drive and maintain good cleanroom management practices

Key requirements:

• Compounding.
• Bachelor’s Degree in Biotechnology, Biology, Chemistry, or equivalent with an Associate degree
• Possess solid critical thinking and problem-solving skills
• Strong understanding of regulations and good manufacturing practices relevant to aseptic manufacture of sterile drug products.
• Significant experience in pharmaceutical aseptic production for drug product manufacture /
• Able to use experience and knowledge to propose solutions (conventional and non-conventional)
• A high school Diploma or Equivalent may be considered with relevant experience

Strong decision-making skills:

• Effective communicator, verbal and written
• Solid interpersonal and teamwork skills, able to work cross-functionally and collaborate with various levels.
• Able to assess options, pros/cons, risks to product/safety/quality/business and aid in prompt decision-making under dynamic conditions.
• Flexible, able to respond to daily changing demands

Strong planning and organizational skills

• Able to have a holistic view of suite planning, at least a month out, and recognize the potential impact and needs as a result of changing demands
• Able to manage a fluid daily schedule

TekWissen® Group is an equal opportunity employer supporting workforce diversity.