Lead Manufacturing Technician

About Pacira

Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results.

Why work with us?

Rarely do you have an opportunity to do work that really matters. What drives us is our mission. What makes us successful are our people. At Pacira, you are part of an inclusive culture that fosters collaboration, growth, and innovative thinking - a place where you can make an impact and help change the standard of care in non-opioid pain management. Be part of our movement, let's pursue excellence together.

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:

• 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, 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
  • Weighing and Dispensing Operation: Performs weigh and dispense operations utilizing protocols and SOPs by weighing required quantity for each material according to Batch manufacturing Record. Use computer system and weighing balance equipment to provide accurate and complete documentation as per company approved procedure.
• Understands critical process parameters and steps of activities sufficiently to act as a trainer for new employees
• Complete and review GMP documentation (Batch Records, Forms, Charts)
• 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 corrections
• Organizational skills and an ability to perform assignments with a high degree of independence
• Work directly with Supervisor to coordinate daily activities for process and personnel
• Maintain scheduling timeline while adhering to GMP and SOP guidelines
• Demonstrate initiative by identifying and implementing process improvements
• Proficient and fully trained in cleanroom gowning and cleanroom practices
• Participate in departmental aseptic process simulation (APS) qualification requirements
• Assist in always maintaining the production areas and records in a cGMP state
• Adhere to all EH&S policies, procedures, and guidelines
• Transact materials in ESI to maintain accurate inventory levels
• Perform routine inventory cycle counts
• Maintaining the production areas and records - OEE spreadsheets, Manufacturing Tracker Spreadsheets and Shift Pass downs.

Supervisory Responsibilities:

This person has no direct supervisor responsibilities.

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 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.

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
• Ability to work a 12-hour shift (includes overtime eligibility)
• Ability to work 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.

Work Environment:

The work setting is consistent of a typical pharmaceutical manufacturing environment with production areas and work stations.

• Medical, Prescription, Dental, Vision Coverage
• Flexible Spending Account & Health Savings Account with Company match
• Employee Assistance Program
• Mental Health Resources
• Disability Coverage
• Life insurance
• Critical Illness and Accident Insurance
• Legal and Identity Theft Protection
• Pet Insurance
• Fertility and Maternity Assistance
• 401(k) with company match
• Flexible Time Off (FTO) and 11 paid holidays
• Paid Parental Leave

The base pay range for this role in California is $32.88 per hour to $45.22 per hour. This role is classified as non-exempt and eligible for over-time. The range is what we reasonably expect to pay for this role. The range considers a wide range of factors that are considered in making compensation decisions, including but not limited to: geographic markets, business or organizational needs, skill sets, experience, training, licensure, and certifications.

EEO Statement: Pacira is proud to be an Equal Opportunity Employer and does not discriminate against applicants because of race, color, religion, sex (including gender identity, sexual orientation, and pregnancy), national origin, age (40 or older), veteran status, disability or genetic information, or any other characteristic protected under applicable federal, state, or local law. At Pacira we are committed to intentionally cultivating a culture of inclusion where all feel welcomed and valued for their background, perspectives, and experiences. We hold one another accountable to promote trust and transparency in support of our communities and collective purpose.
Agency Disclaimer: Pacira Biosciences, Inc. (Hereafter, Pacira) does not accept unsolicited resumes from recruiters or employment agencies in response to the Pacira Careers page or a Pacira social media post. Pacira will not consider or agree to payment of any referral compensation or recruiter fee relating to unsolicited resumes. Pacira explicitly reserves the right to hire said candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Pacira.