Pacira BioSciences, Inc.
Sr. Process Engineer
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At Pacira, innovation meets purpose. Pacira BioSciences, Inc. is a pioneer in non-opioid pain management and regenerative health solutions. Today, we’re building on that legacy with next-generation innovations for chronic, postsurgical, and musculoskeletal pain. Our culture is built on collaboration, innovation, and a shared commitment to helping patients recover faster. We are redefining what’s possible in pain management—and we can’t do it without talented people like you.
Why Join Us?
At Pacira, every career is more than a job. Our mission drives us, and every day, we challenge ourselves to achieve the extraordinary. Integrity is at the core of who we are. We value diverse perspectives and the collective strength of a unified team. Join the team in making better possible for patients everywhere.
Summary:
This position will serve as the technical expert for EXPAREL and ZILRETTA commercial production at our United Kingdom CMO facility. Additionally, the role provides technical support to clinical and commercial operations. It focuses on leading projects for improving and optimizing operations through implementation of new technology, providing support in areas such as data analysis identification of potential process bottlenecks and vulnerabilities, investigations into process events.
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.
- Act as the subject matter expert (SME) for EXPAREL and ZILRETTA manufacturing, with responsibilities including addressing real-time process related questions, deviation investigations, oversee execution of investigations in support of raw material or process related
- Lead investigational teams with support from SCC on process and/or product related issue for commercial production when
- Possess a continuous Improvement (CI) mindset to drive improvements, considering CI principles for new product development and ensuring production processes are operationally cost effective.
- Support installation of new / replacement process equipment in a highly regulated Provide technical input into machinery purchases and investigation of new technologies for existing processes.
- Aid in communication between SCC and Patheon for scheduling raw material investigations and also the reporting of results for these
- Provide support to Validation and Quality personnel during commission and validation
- Provide oversight on site 3rdparty vendors and manage site engineering consultants as
- Assist in product and process training of CMO engineers, QA personnel, QC personnel and manufacturing operators for EXPAREL and ZILRETTA production, sterilization, and cleaning
- Execute engineering studies and comparability protocols.
- Lead, support and implement initiatives in designs to mitigate down time on production lines and Continuous Improvement initiatives (CI).
- Provide timely report updates and information pertaining to manufacturing and projects.
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Supervisory Responsibilities:
This role does not have supervisory responsibilities.
Interaction:
The incumbent works closely with employees at Pacira UK and Pacira SCC and management in all functional areas as well as with external vendors, contractors, and consultants.
Education and Experience:
- Minimum 8 years of experience in a pharmaceutical environment including regulatory requirements associated with FDA / EMEA required
- BS degree in Engineering from an accredited college or university required
- Extensive cross-functional team experience, including technical and non-technical work required
- Successful track record of project execution required
- Experience in Aseptic Manufacturing Processes desirable
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Knowledge, Skills, and Abilities:
- Experience working with a CMO environment and excel at working with cross-functional/cross-company teams
- Experience with typical clean plant utilities, aseptic processing, pharmaceutical processing equipment, SIP and/or CIP
- Well versed in working in a GMP environment including procedures and documentation utilized by regulatory agencies such as FDA, MHRA, EMEA and others
- Experience transferring experimental study design and execution from one site to another
- Demonstrated results-driven leadership, and managerial skills, especially in execution of complex projects (ideally through a CMO)
- Excellent skills in planning, organization, coordination, control, attention to detail, decision-making, and execution
- Ability to initiate and manage multiple responsibilities with a high degree of flexibility, self-motivation, independence, and tolerance to stress
- Ability to work effectively through influence and guidance and achieve success in a fast-paced, rapidly changing environment
- Ability to take initiative and function with a “roll up the sleeves” approach
- Excellent critical thinking and problem-solving abilities and ability to grasp complex concepts, systems and their accompanying documentation
- Excellent oral, written and interpersonal English communication skills with good presentation skills and solid writing skills that clearly communicate intent and instructions in SOPs,
- Demonstrated computer proficiency (g., word processing, spreadsheets, graphing, Microsoft Office, Auto CAD, and Minitab)
- Ability to work both independently and in a team environment
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Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms and stoop. Close vision and the need to focus on computer screen, use of hands, fingers and wrist to type on keyboard and manipulate mouse.
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