Senior Validation Engineer
Job Description
Description
The base pay range for this role in California is $21.15per hour to $29.09 per hour. This role is classified as non-exempt and eligible for over-time.
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.
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.
Each of our 3 marketed products, both in pharmaceutical and medical device, represent cutting edge technologies for pain management.
We have 700+ employees and have averaged double digit growth year over year for the past 5 years, with $500M in revenue. We are small enough for you to make your mark, and big enough for you to learn and grow!
We have facilities in New Jersey, California and Florida. Our San Diego, CA campus is a world class manufacturing and R&D facility. We are rapidly growing and have opportunities across all of our sites and functional areas.
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.
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 primary purpose of this position is to support the overall Validation Program by conducting qualifications and preparing and/or executing validation documents. This includes the generation, development, modification and routing of Validation Protocols, Final Reports, Standard Operating Procedures and Change Controls.
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.
- Write, review and/or approve Protocols, Deviations, Final Reports, SOPs, and Change Controls with emphasis on complex software and computerized control systems.
- Lead the validation and revalidation testing process including data collection, analysis and deviation resolution.
- Mentor personnel with respect to software and computer validation.
- Provide subject matter expertise during inspections and regulatory audits.
- Perform other duties as directed by supervisor.
Supervisory Responsibilities:
This person has no direct supervisor responsibilities but is expected to offer technical leadership to less senior staff members.
Interaction:
The incumbent works closely with the Manufacturing, Product Development, Engineering, Facilities, Calibration, and Quality departments.
Education and Experience:
- 8 years of relevant pharmaceutical validation experience preferred
- BS degree in a science or engineering related discipline highly desirable
- Strong technical writing skills for validation Protocols, Deviations, Final Reports, SOPs and Change Controls for computerized systems, complex automation and/or software required
- Cleaning Validation Experience with process system (CIP Vessels, and Parts Washer) required
- Ability to temperature map refrigerators, incubators and freezers
- Familiar with Autoclave and SIP (Temperature mapping with Biological Indicators)
- Experience with Utility Qualifications (WFI, RODI, CCA, N2, HVAC) required
- Experience with Aseptic Process Simulations (APS) for Process Skids and Filling Lines
- Familiar with Filling Lines (Vial Washer, Depyrogenation Tunnel and Fill Line)
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:
- Able to read P&IDs
- Advanced understanding and practice of cGMPs
- Advanced software proficiency - word processing and spread sheet applications
- Understanding of validation principals and techniques for software and computerized systems as applied in the pharmaceutical industry
- Ability to work in an organized and detail-oriented fashion
- Ability to manage multiple responsibilities with a high degree of self motivation
- Ability to work both independently and in a team environment
- Excellent oral, written, and interpersonal communication skills
- Experience with IQ, IOQ, OQ, PQ and Validation Summary Reports
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. Will need to lift and move boxes of paper and binders weighing up to 20 pounds.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
The primary work environment is a typical office setting with offices and cubicles. Noise level is moderate with consistent printer, telephone ringing and conversation. Employee may be required to work in a lab or manufacturing area in order to perform some duties. Work in a clean room environment may be required; must be able to gown and demonstrate proper conduct in a clean room environment. Employee may work with or near high voltage electronics, 80C water systems, and high pressure steam systems.
Benefits:
- 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 $21.15per hour to $29.09 per hour. This role is classified as non-exempt and eligible for over-time.
The range iswhat 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.
*Please mention you saw this ad on AcademicJobs.*
