Process Validation Engineer II

Johnson & Johnson Innovative Medicine•Raritan, NJ

1d•$65,000 - $104,650•Hybrid

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. About Innovative Medicine Our 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 https://www.jnj.com/innovative-medicine 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.

Requirements

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.

Nice To Haves

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

Responsibilities

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

Benefits

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