Director- Process Engineering & New Technology (Bulk-Fill/Aseptic)

Technical Operations San Diego, CA


Description

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 lead the application of engineering to the design of commercial and clinical scale equipment and supporting utilities and facility.

Essential Duties & Responsibilities:

The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job.  Other duties may be assigned.

  • Establish and provide leadership to the Engineering organization comprised of process and new technology.
  • Provide management support and oversight to the Engineering & Automation / Metrology functions.
  • Drive key reliability and cycle time improvement projects in support of Operations and Facilities.
  • Design and maintain commercial processes, equipment, controls, and facilities design, development and transfer to internal and contract manufacturing sites.
  • Develop department plans, strategies and budgets that are aligned with company goals and objectives.
  • Development of CIP and SIP processes for the company’s products.
  • Participate in technology transfer to within the company and to partners.
  • Provide technical support to commercial operations.
  • Support GMP audits from regulatory agencies as well as internal audits.
  • Provides responses to any findings related to the facilities, manufacturing equipment or calibration programs.
  • Comply with Health, Safety and Environmental regulations.
  • Maintain an up to date knowledge of GMP and EU requirements, practices and procedures and informs other members of the facility of those requirements.
  • Interfaces with and coordinates activities of external contractors and services when required.
  • Responsible for the preparation and management of the department budget.
  • Responsible for headcount allocations and justifications.
  • Evaluate and define commercial processes and equipment, technology transfer, establishing and implementing project plans and budgets, and providing technical support to ongoing operations and R&D.
  • Provide leadership support in organizing activities associated with Regulatory Inspections.
  • Cooperate with Regulatory Affairs in preparation of filings and submissions, as well as prepare responses to agency request for information.
  • Establishing and maintaining contemporary engineering systems, practices and requirements.

Education and Experience:

  • 10-15 plus years of relevant pharmaceutical industry experience.
  • Preferred BS, MS degree in Chemical / Mechanical Engineering or equivalent experience.

 Knowledge, Skills, and Abilities:

  • Proven ability to lead and manage cross functional teams, projects and direct reports.
  • Experience in scale up of pharmaceutical / biotechnology products
  • Knowledge of and familiarity with mixing/emulsion/surface chemistry, heat/mass transfer, principles of physical chemistry and chemical engineering.
  • Knowledge of aseptic process, CIP and SIP processes desired.
  • Knowledge of instrumentation and controls principles.
  • Experience with pilot-scale pharmaceutical / biopharmaceutical process equipment.
  • Perspective as to what constitutes a readily scaleable, commercializable process.
  • Desire to solve difficult problems using scientific methods and DOE.
  • Ability to effectively utilize scientific information resources within the assigned areas of responsibility.
  • Ability to work effectively, both independently and as an integral contributor toward the achievement of project and company goals.
  • Ability to manage multiple responsibilities and projects, with a high degree of self-motivation.
  • Ability to work and comply with cGMP requirements
  • Good observation skills and problem solving abilities.
  • Effective oral, written, and interpersonal communication skills.
  • Ability to manage and lead a small internal and large external validation technician staff with enthusiasm.
  • Experience with aseptic fill products, emulsions, therapeutic proteins, and unique delivery systems.
  • Strong technical presentation skills.

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.