Senior Validation Engineer San Diego, California, United States

Company: Project Farma
Location: San Diego
Posted on: November 13, 2024

Job Description:

Welcome to the forefront of innovation in cutting edge patient treatments! We are thrilled to present an incredible opportunity to join our high performing organization. As a leader within the life science industry, we are constantly pushing the boundaries of what is possible and redefining the standards of excellence. Our dynamic team is composed of vibrant professionals who are passionate about delivering high quality work for our partners and changing the lives of patients across the globe. If you are driven by innovation, thrive in a fast-paced environment, love to travel and are ready to make a real impact, then Precision for Medicine, Manufacturing Solutions wants you to join our team.Who Are We?We are Precision for Medicine, Manufacturing Solutions, the leading advanced therapy technical operations consulting company in the life science industry. As aPatient Focused,People Firstdelivery team, we are committed to advancing manufacturing to achieve operational excellence and accelerate speed to market for next-generation medicines. Our manufacturing playbook has led to the creation of the largest and most mature advanced therapy manufacturing footprint in the world. We are an industry leader in providing project management, validation, engineering, quality/compliance, and consulting services to support our partners across the life science space in finding ground-breaking treatments and solutions. We believe that our culture of philanthropy, teamwork, training and development and commitment to the patient is the foundation to our teams' and partners' long-term success.Essential Job Function (Include but are not limited to):

• Create alignment with cross-functional client departments including but not limited to Validation, Manufacturing, Quality, Supply Chain, and Engineering.
• Provide hands-on support and troubleshooting for clients navigating the engineering life cycle of cutting-edge equipment and manufacturing processes.
• Perform due diligence on system and subject domains to generate high-quality project deliverables.
• Author technical documents such as SOPs, requirements specifications, testing protocols, summary reports, etc.
• Execute system and process validation protocols using GxP best practices.
• Proactively identify and escalate roadblocks and utilize critical thinking skills and knowledge of problem-solving skills to identify creative solutions to those problems and roadblocks.
• Contribute to and embody ourPatient FocusedandPeople FirstMission through the involvement in professional development and philanthropic opportunities.
• Build meaningful internal and external relationships presenting Project Farma as a service to clients as needed.Qualifications:
  Education and Experience Required:
  • Bachelor's degree in Life Science, Engineering, or related discipline and/or comparable military experience.Other Required:
    • Covid Vaccine is required prior to the Team Member's start date with exceptions for medical and religious accommodations when reasonable.
    • Full time on-site client presence
    • Willingness to travel up to 100% or as required to support project and business needs.In return for your skills, knowledge, and passion, Project Farma offers a wide range of benefits including:
      • Competitive salary based on experience
      • Aggressive bonus structure
      • Medical, Dental, and Vision insurance effective your first day of employment
      • 401k Plan with company match
      • Paid Time Off and Company Paid Holidays
      • Company Paid Maternity and Parental Leave
      • Continuing Education Assistance Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits. Reasonable estimate of the current range$63,800 - $69,300 USDAny data provided as a part of this application will be stored in accordance with ourPrivacy Policy. For CA applicants, please also refer to ourCA Privacy Notice .If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com . It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Accepted file types: pdf, doc, docx, txt, rtfAccepted file types: pdf, doc, docx, txt, rtf LinkedIn Profile * What is your desired salary? * Are you located within 45 minutes of the city in the job posting (San Diego, CA) and/or willing to relocate? Please account for traffic. * Select... Do you have a planned vacation within the next 3 months? If yes, for when and how long is your planned trip? * Are you comfortable with up to 100% travel? * Select... What attracted you to Project Farma? * Why are you passionate about working in the pharmaceutical space? * Are you authorized to work lawfully in the country/location for which you are applying? * Select... Will you now or in the future require Precision Medicine Group to commence (sponsor) an immigration case in order to employ you (for example, work visa application or work visa transfer, or other-employment based immigration case)? This is sometimes called "sponsorship" for an employment-based visa status. * Select... Have you ever worked for Precision Medicine Group or one of its affiliated companies? * Select... If yes, when and which company? Are you currently subject to a Non-Compete or Non-Solicit with your current employer? * Select... Legal Address - Street Address 1 * Legal Address - Street Address 2 Legal Address - City * Legal Address - State * Select... Legal Address - Zip * Legal Address - Country * Select... I certify that the information on this application, my resume and any supporting documentation I provide is complete and accurate to the best of my knowledge.If this application leads to employment, I understand that false or misleading information in my application, resume or interview may result in my release or termination of employment.I authorize the Company or its agents to confirm all statements contained in this application and/or resumes as it relates to the position I am seeking and to the extent permitted by federal, state, or local law. I agree to complete any required authorization forms for the background investigation.I authorize and consent to, without reservation, any party or agency contracted by this employer to furnish the above-mentioned information. I hereby release, discharge, and hold harmless, to the extent permitted by federal, state, and local law, any party delivering information to the Company or its duly authorized representative pursuant to this authorization from any liability, claims, charges or causes of action which I may have as a result of the delivery or disclosure of the above requested information and all other persons, corporations, or organizations furnishing such information.If hired I understand that I will be required to provide genuine documentation establishing my identity and eligibility to be legally employed in the United States. I also understand that the Company employs only individuals who are legally eligible to work in the United States.This application will remain active for 60 days. Any applicant wishing to be considered for employment after that time must reapply.UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100. * Select... Voluntary Self-IdentificationFor government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.As set forth in Project Farma's Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Select... Voluntary Self-Identification of Disability Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026 Voluntary Self-Identification of Disability Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026
        Why are you being asked to complete this form?We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp .How do you know if you have a disability?A disability is a condition that substantially limits one or more of your "major life activities." If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:
        • Alcohol or other substance use disorder (not currently using drugs illegally)
        • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
        • Blind or low vision
        • Cancer (past or present)
        • Cardiovascular or heart disease
        • Celiac disease
        • Cerebral palsy
        • Deaf or serious difficulty hearing
        • Diabetes
        • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
        • Epilepsy or other seizure disorder
        • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
        • Intellectual or developmental disability
        • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
        • Missing limbs or partially missing limbs
        • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
        • Nervous system condition, for example, migraine headaches, Parkinson's disease, multiple sclerosis (MS)
        • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
        • Partial or complete paralysis (any cause)
        • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
        • Short stature (dwarfism)
        • Traumatic brain injury Disability Status Select... PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.
          #J-18808-Ljbffr

Keywords: Project Farma, Laguna Niguel , Senior Validation Engineer San Diego, California, United States, Engineering , San Diego, California