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Job Function: Supply Chain Engineering
Job Sub Function: Process Engineering
Job Category:Scientific/Technology
All Job Posting Locations:Raritan, New Jersey, United States of America
Job Description:About Innovative MedicineOur expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way!
Learn more at ;/b>
We are searching for the best talent for a Process Validation Engineer II to join our Team! This is an onsite/hybrid role.
Position Summary:
The Process Validation Engineer II will support and drive the initiative to establish a robust and sustainable continuous process validation program for the Lentiviral Vector and CAR-T products leading up to commercial launch and through the life cycle of the program.
The Process Validation Engineer II will:
- Prepare well documented protocols and reports for all processes to be qualified/validated based on corporate/site guidelines, procedures, regulatory guidelines, and industry practices
- Coordinate and support the execution of validation activities with related departments and stakeholders (for example technical groups as Engineering, Manufacturing, Quality Control, Quality Assurance and others as applicable)
- Evaluate process/equipment performance during qualification/validation studies in order to determine acceptability, reproducibility, and control.
- Support investigations resulting from deviations associated with process validation activities and provides oversight of pre-validation and validation activities resulting from technical changes.
- Propose and formalize alternatives for enhancement to qualification and validation processes and procedures in order to support process validation from a lifecycle perspective and ensure the program is sustainable.
- Support aseptic process validation from protocol generation, training execution, oversite, and reporting standpoint.
- Support equipment performance qualification and ensure consistency with process needs defined by Manufacturing or Tech Support.
- Support the Continuous Process Verification (CPV) plan with providing data review/assessment and periodic reports.
- Support the establishment of KPIs.
- Support APQ/APQR site reporting with data analysis and evaluation
- Provide technical assessments, rationales, and approval for engineering and process changes to meet regulatory requirements.
- Provide backup support to the Validation Manager and fellow engineers during absence.
- Assist management during internal and external regulatory audits.
- Support writing of Quality Risk Assessments for existing and new/changed processes
Qualifications - External
Required:
- A minimum of a Bachelors degree in a Scientific or related field is required
- A minimum of 2-4 years of professional relevant business experience.
- Experience with drafting and executing process validation protocols/reports is required
- GMP manufacturing and/or validation experience in pharmaceutical manufacturing is required.
- Familiarity with regulatory guidelines pertaining to process validation is required
- Excellent written and oral communication skill are required
- Open to up to 10% of travel.
Preferred:
- Cell and Gene Therapy experience is preferred
- CAR-T manufacturing experience is preferred
- Aseptic processing experience is preferred
- Ability to utilize various standard programs for data entry and word processing is preferred.
- Ability to learn and operate various enterprise systems including eLIMS, Trackwise, Maximo, EMS, BMS, SAP is highly desirable
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via or contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Analytical Reasoning, Computerized Equipment Skills, Corrective and Preventive Action (CAPA), Emerging Technologies, Execution Focus, Gemba Kaizen, Issue Escalation, Lean Supply Chain Management, Process Control, Process Engineering, Process Oriented, Product Improvements, Project Engineering, Safety-Oriented, Science, Technology, Engineering, and Math (STEM) Application, Situational Awareness, Technical Research, Technologically Savvy
The anticipated base pay range for this position is :
$65,000.00 - $104,650.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
Additional information can be found through the link below.
For additional general information on Company benefits, please go to: -
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