Technical Writer

cGMP Consulting, Inc. is seeking technical writers who would support engineers of all experience levels to provide technical support/ documentation to Engineering and Validation teams for facility, equipment, and utility (FUE) qualification for a variety of on-going projects in the pharmaceutical industry. Position activities include FUE commissioning, qualification, validation, risk assessments, troubleshooting, problem-solving, and ensuring compliance with FDA and Industry standards. Knowledge and application of the CFR’s and cGMP’s is preferred.

cGMP Consulting is looking for an individual who is efficient, comfortable working independently, and who will handle multiple projects and priorities, work with tight deadlines, address high priority requests, and will be expected to “roll up your sleeves” to problem solve and move productively. The ideal candidate for this job is resourceful, independent, organized, and capable of working in a fast-paced environment. Assuring a steady and accurate completion of the workload on time is key to success in this position.

Responsibilities

• Perform equipment commissioning testing in conjunction with Engineering for new equipment.
• Perform validation/qualification studies (utility, equipment, cleaning, process computer, and new products) to include writing Risk Assessments, protocol preparation, scheduling, protocol execution, and final report preparation.
• Program and operate department analytical instruments (such as temperature/humidity dataloggers) to perform controlled temperature/humidity chamber qualifications (examples lyophilizers, warehouses, sterilizers, incubators, etc.).
• Represent Technical Services in teams assembled to specify, install, validate, troubleshoot and maintain systems, equipment and processes.
• Work with process experts and production personnel to fully understand and solve problems.
• Provide technical expertise and recommend improvements.
• Utilize Word, Excel and other electronic systems to complete tasks.
   

Requirements

• • Minimum 4-year degree in Engineering or related field.
  • Ability to read and translate blueprints and technical drawings.
  • Basic understanding of building design and mechanical processes.
  • Ability to work as part of a team and individually on projects.
  • Working knowledge of cGMP practices including Good Documentation Practices.  Working knowledge of FDA, USP, ISO, and ISPE trends and guidelines.
  • Excellent time management skills.
  • Strong communication skills.