Environmental Monitoring Coordinator

Just-Evotec Biologics is seeking an Environmental Monitoring Coordinator to join a fast-paced, collaborative and multi-disciplinary team for the advancement to improve worldwide access to biotherapeutics. The objective of the EM Coordinator position is to develop and coordinate the Environmental Monitoring Program of ISO-classified areas following the Good Manufacturing Practices (GMP). This position will be responsible for overseeing Day/Swing/Night shifts and to cover 24/7 micro cleaners' operation and require significant on-the-floor presence, as well as technical subject matter expertise in micro cleaning for pharmaceutical manufacturing industries. Initially, EM Coordinator is expected to assist in commissioning, validation, and other start-up activities related to the environment for the GMP area.

Responsibilities:

• Ensure level of micro cleaning personnel is adequate for specific GMP areas and the micro cleaning personnel is adequately trained and qualified to perform the micro cleaning service in ISOs rooms.
• Work with Compliance and Training manager to ensure training certifications levels meet requirements, and staff is current on all applicable training for their assigned area.
• Ensure that all SOPs are properly taught and followed.
• Watch periodically, the micro cleaning activities to guarantee the micro cleaners are following the GMP and Good Documentation Practices (GDP).
• Review all assigned documentation for entry errors and initiate correction process immediately to ensure all corrections are made in compliance to SOP.
• Track entry errors by area and by type and compile data into MS excel spreadsheet.
• Perform initial hands-on On Job Training to ensure the micro cleaners technicians have the ability to: 1) understand and be able to mix chemicals properly and understand the dwell time for all chemicals; 2) apply chemicals to floors, ceilings, walls, fixtures in conjunction with the proper equipment; 3) follow all the steps from the procedure.
• Perform hands-on inspections to ensure: 1) all dwell times are adhered to in accordance with SOP's and are being accurately recorded in log book entries; 2) appropriate level of clean is being performed according to SOPs; ensure all chemical related documentation is accurate including lot numbers and expiration date.
• Provide clarification to any SOP from job responsibilities as necessary upon request.
• Partner with management to review any deviations and assist with investigations and audits from client or regulatory agencies
• Develop new procedures as required and ensure appropriate training is executed.
• Ensure that all deviation corrections are in place and re-training is facilitated.
• Recognize and report deviations from procedures.
• Ensure compliance with company quality systems, safety procedures, and other company policies.
• Manage the cleaning supplies and gowning stocking for GMP area.
• Other duties as assigned.

Requirements:

• B.S. degree in Biology or equivalent education in a related field of study preferred.
• Minimum 3 years experience in cleanroom environment.
• Proven knowledge of cGMP requirements to ensure compliance with the industry standards for the cleanroom environment.
• Previous cleanroom environment experience.
• Candidate must possess strong focus on quality and attention to details.
• Capacity to develop solutions to technical solutions of moderate scope.
• Ability to read, understand, follow, and implement all applicable SOPs (Standard Operating Procedure), policies, and procedures.
• Ability to become qualified as a “train the trainer” on Just Evotec Biologics SOPs for the area of responsibility and site wide as appropriate.
• Ability to work flexible hours including holidays, weekends, overtime, be on-call and available for special assignments.
• Available to work various shifts.
• Good oral and written communications skills.

Preferred qualifications:

• Demonstrate thorough knowledge of GMP Pharmaceutical operations

About Just - Evotec Biologics

Just - Evotec Biologics, wholly-owned by Evotec SE, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Just's focus is to create access and value for a global market through scientific and technological innovation. Our state-of-the-art labs and cGMP clinical manufacturing plant are co-located in Seattle's South Lake Union neighborhood - the center of Seattle's medical, global health, and technology industries and a noted top emerging life science hub in the U.S. Our fast-growing team of 200 employees is expanding Just's innovative platform and footprint - building our first North American J.POD® commercial manufacturing facility in the Seattle area. For job opportunities, learn more at www.just.bio/careers