The purpose of the Manufacturing Senior Bulk Operator is to perform tasks and operations in either the bulk manufacturing or filling operations required in the preparation for and sterile production of liquid injectable, sustained release pharmaceutical products under cGMP regulations.
These products are manufactured under the most stringent of conditions, and a strong work ethic and pride of workmanship are a must.
The selected candidate has the technical training to qualify as an operator or verifier in multiple tasks in the bulk and/or the filling manufacturing operational areas in the pharmaceutical production of all products manufactured at Pacira’s San Diegofacilities.
Bulk Manufacturing: Perform operations in CIP, SIP, and solution prep, take responsibility for set-up and preparation of the area for bulk manufacturing, utilize automated control systems, and other routine tasks
Filling Operation: Prep parts, run the vial washer/depyrogenation tunnel, autoclave, capping machine, tray loader, support the filling line, aseptic gown qualify, maintain aseptic qualification, inspect finished product
- Understands critical process parameters and steps of activities sufficiently to act as a trainer for new employees
- Complete GMP documentation (Batch Records, Forms, Charts, Data Entry )
- Read, comprehend, and adhere to standard operating procedures (SOPs)
- Participate in development and production of pipeline products
- Author or assist in drafting and revising of departmental procedures and practices
- Identify and communicate floor observations to supervisory staff
- High level of proficiency with process equipment and automated control systems with the ability to troubleshoot, escalate issues and determine correction
- Organizational skills and an ability to perform assignments with a high degree of independence
- Proficient and fully trained in cleanroom gowning and cleanroom practices
- Participate in departmental aseptic process simulation (APS) qualification requirements
- Assist in maintaining the production areas and records in a cGMP state at all times
- Adhere to all EH&S policies, procedures, and guidelines
- 12 hour shift schedule
Qualifications, Education, and Experience:
- A minimum of 5 years of industry experience in the pharmaceutical or a closely-related industry required. However, exceptions may be made based on relevant educational degree.
- A high school diploma/GED is required. Relevant experience may be substituted for diploma/GED requirement.
- Bachelor’s degree from an accredited college/university may be substituted for industry experience.
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Knowledge, Skills, and Abilities:
The selected candidate must satisfactorily complete a Drug Enforcement Agency (DEA) background check prior to securing employment at Pacira.
The selected candidate shall possess the following fundamental skills:
- The ability and willingness to work as a member of a team, good interpersonal skills
- Ability to work with minimal direct supervision and is self-driven to meet the schedule
- Must have good attention to detail, documentation skills, and the ability to follow written procedures in a GMP environment
- Must possess strong written and verbal English communication skills
- Must have strong organizational skills and the ability to multi-task
- Ability to operate in a cleanroom environment
- Must understand and be proficient with basic arithmetic calculations, including calculating elapsed time and ratio calculations
- Computer proficiency, including knowledge of Microsoft Word, Outlook, and Excel applications is required
- Ability to accommodate production requirements that may occasionally require 50+ hour workweeks, including extended day hours and weekends