Fill Finish Specialist

Job Locations US-MD-Silver Spring
# of Openings
1
Category
WRAIR PBF
Type
Regular Full-Time

Overview

CAMRIS International is a medical research and development firm that realizes innovative solutions to health and development challenges through high-quality, cost-effective program and research management services. We combine our proven systems with today’s most effective, evidence-based best practices to improve the lives of people around the world. Our core practice areas include HIV/AIDS, microbiology and infectious disease research, vaccine research, development and production, global health security, biodefense, and clinical research.  This position will support the Pilot Bio-Production Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland.

Responsibilities

  • Perform all manufacturing operations under cGMP requirements.
  • Display understanding of filling operations, equipment operation (filling pumps, crimpers, etc.), aseptic media fills, and filling regulations.
  • Perform visual inspection of vials.
  • Can perform aseptic work inside a glove box and hoods.
  • Prior to start-up, during processing, and at the completion of the manufacturing process, adhere to and perform all documentation and clerical functions to provide the proper accountability and traceability of components and finished product.
  • Perform bulk thaw, filling, and formulation operations.
  • Set up equipment/machines aseptically for proper operation, including installation and disassembly of equipment and parts required for filling and formulation operations.
  • Assists/writes SOPs (Standard Operating Procedures), batch records, and other GMP documentation.
  • Perform legible, clear, and concise data entry into batch records, logbooks, and all other ancillary controlled forms used in a cGMP process. Adheres to current Good Manufacturing Procedures (c GMP) guidelines and FDA regulations as they apply to all levels of work.
  • Maintain a high level of quality and compliance with regards to all aspects of manufacturing.
  • Execute corrective measures addressing any issues in a timely manner.
  • Ability to contribute to process improvement plans and help drive to completion.
  • Firm understanding of GMPs and can identify and escalate potential GMP issues.
  • Available to work various shifts (e.g., Days, Holidays) ad hoc as needed and as directed by the production schedule.

Qualifications

  • Associate's or Bachelor's degree in Science or Engineering or equivalent industry experience and 5+ working in a GMP manufacturing or regulated laboratory environment.
  • Strong communicator with ability to work independently and effectively as part of a team.
  • Proven experience in maintaining detailed records and ability to assist in document revisions. Highly capable of keeping accurate records and performing mathematical calculations.
  • Strong understanding of cGMPs as related to commercial and clinical filling operations
  • Understands the basic cleanroom behaviors, including ISO clean rooms and functions.
  • Strong computer skills including MS Office (Word, Excel) Effective problem-solving skills.
  • Proven ability to establish and maintain effective working relationships with team members and managers.
  • Technical understanding of a vaccine manufacturing facility.
  • Knowledge of cell culture and/or protein purification a plus.
  • Experienced in startup of a new facility.
  • Experience with single-use technologies.
  • Ability to support general investigations and CAPA execution.
  • Ability to multi-task, be flexible and to thrive in a fast-paced environment, as well as the capacity to handle changing priorities
  • Knowledge of aseptic technique, cGMP, or FDA regulations.
  • Working knowledge of disposable manufacturing methodology such as the use of sterile bags with tubing and tubing welders.

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