Department: Research and Development
The primary responsibility of the Validation Supervisor is the supervision and hands-on support of developing and implementing validation processes to ensure that the process equipment, procedures and systems used in the manufacture of Leukocyte Interleukin, Injection (LI) meet regulatory requirements, industry standards and cGMP practices. This person will manage documentation as it relates to validation processes and procedures. Will also supervise and coordinate validation work for the Research and Development department. The Validation Supervisor is expected to have excellent verbal and written communication skills and interact with department heads regularly. Reports to the Director of Research and Development.
1 B.S. in a related discipline and 5+ year(s) relevant experience in a related field
- M.S. in a related discipline and 3+ year(s) relevant experience in a related field
- Ability to follow and master Standard Operating Procedures (SOPs)
- Demonstrate mastery of current Good Manufacturing Practices (cGMP)
- Familiarity with and knowledge of guidance documents to include FDA, ICH, and EU Guidelines for Validations of drugs and Parenterals
- Provide supervision and project guidance to external contractors and/or junior staff
- Convey knowledge and understanding of the validation process for cGMP activities
- Able to plan validation schedules and execute and supervise the plan successfully
- Ability to analyze Validation data/information and summarize it in tabular and graphic form as necessary
- Ability to write Master Validation Plans, Protocols and Reports
- Able to work in an ISO classified work environment
- Participate in and help in delivering required safety, GMP, and technical training sessions
Principal duties of the Validation Supervisor include the following:
- Implements programs for Validation under direction from the Director of Research and Development or the Associate Director of Research and Development
- Collaborates with Quality Assurance to address quality standards for GMP equipment and systems
- Ensures compliance with FDA and EU requirements by frequent review of applicable Regulations and Guidance documents
- Performs, collects and analyzes data for Installation/Operation/Performance Qualifications and other data, as required – assigned
- Prepares and reviews IQ/OQ/PQ and calibration reports, summarize, present and communicate findings and suggests solutions, as needed
- Administers Change Control documentation
- Maintain at least read-to-know proficiency on the use and maintenance of Manufacturing equipment and facilities
- Maintain at least read-to-know proficiency in the LI Manufacturing Process
- Maintain at least read-to-know proficiency in facility environmental requirements
- Maintain equipment files and binders
- Audit and maintain training documentation for Validation employees
- Other duties as assigned
The position is full time.
This position may require periodic local travel between CEL-SCI Facilities, to contract facilities, and to external Validation providers.
Baltimore & Elkridge, MD
We offer competitive salaries, outstanding comprehensive benefits, and Employee Stock Options.
Please submit cv/resume and cover letter to firstname.lastname@example.org along with salary requirement. Reference the job title in the subject line of the email.
CEL-SCI Corporation is committed to a policy of equal employment opportunity. CEL-SCI will recruit, hire, train, and promote into all job titles the most qualified individuals, without regard to race, color, creed, protected veteran status or disability, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.