Manufacturing Technician 1

Technical Operations San Diego, CA


Description

 

Summary:

The purpose of this position 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 Diego facilities.

 

Essential Duties & Responsibilities:

  1. Areas of assignments are as follows:

Bulk Manufacturing: Perform operations in CIP, SIP, and solution prep, take responsibility for set-up and preparation of the area for bulk manufacturing, 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

  1. Complete GMP documentation (Batch Records, Forms, Charts)
  2. Read, comprehend, and adhere to standard operating procedures (SOPs)
  3. Participate in development and production of pipeline products
  4. Identify and communicate floor observations to supervisory staff, perform basic troubleshooting
  5. Proficient and fully trained in cleanroom gowning and cleanroom practices
  6. Participate in departmental aseptic process simulation (APS) qualification requirements
  7. Assist in maintaining the production areas and records in a cGMP state at all times
  8. Adhere to all EH&S policies, procedures, and guidelines

 

 Interaction:

The individual will be required to collaborate with the manufacturing, supply operations, plant operations, quality, engineering, and process research and development groups within Pacira.

 

Qualifications, Education, and Experience:

  • A minimum of 1 year 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

 

Physical Demands:

While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, and reach with hands and arms.  Close vision and the need to focus on computer screen, use of hands, fingers, and wrist to type on keyboard and manipulate mouse.  Will need to lift and move items weighing up to 50 pounds.

Employee is required to work in a cleanroom environment, which requires gowning consisting of coverall, foot and head coverings, facemask, and gloves.  Noise level is moderate with consistent equipment operation.