Experienced Engineer - Cleaning Validation

Johnson & Johnson Innovative Medicine; Wilson (NC); On-site; USD 79,000 - 120,000; Full time

Job summary

Johnson & Johnson is seeking an Experienced Engineer, Process Engineering to join our MSAT team in Wilson, NC. The role focuses on process technology for biotherapeutics with emphasis on cleaning validation and lifecycle management in a new bioprocessing facility.

The Senior MSAT Engineer will develop protocols, validate processes, and coordinate multi-disciplinary activities to ensure compliant, efficient manufacturing operations in a regulated environment.

Qualifications

• Degree in Life Sciences, Engineering, Biology, Biochemistry, or related field is required.
• Excellent verbal and written communication with internal and external customers.
• Proficient with MS Office, Excel and SAP.
• At least 3 years in pharmaceutical manufacturing or equivalent.
• Able to work independently with minimal supervision to meet deadlines.

Responsibilities

• Conduct MSAT activities in compliance with FDA/EMEA regulations and EHS&S.
• Lead Cleaning Validation activities: cycle development, PQs, hold studies, re-qualification.
• Develop MSAT documentation and coordinate reviews/approvals.
• Review documents and perform field execution of MSAT protocols.
• Coordinate with manufacturing and vendors; manage technical reports.
• Track exceptions and prioritize MSAT activities per schedule.

Skills

Communication skills

Independent work

Education

Bachelor's degree in Life Sciences or related field

Tools

MS Office

Excel

SAP

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.

Job Function

Supply Chain Engineering

Job Sub Function

Process Engineering

Job Category

Scientific/Technology

All Job Posting Locations

Wilson, North Carolina, United States of America

Job Description

Johnson & Johnson is currently seeking a Experienced Engineer, Process Engineering to join our Manufacturing Science and Technology team

located in Wilson, NC.

Job Summary

Manufacturing Science and Technology (MSAT) manages the process technology platform strategy for the production of biotherapeutics in the new Bioprocessing Facility in Wilson, North Carolina. We are responsible for Process & Cleaning Validation, Standardization of Equipment for New Product Introduction, and Life Cycle Management (LCM) of our commercial production processes.

Essential Job Duties And Responsibilities

The Experienced Engineer Will Be Responsible For The Following

• Conduct MSAT activities in compliance with US and EU regulations, local and global procedures and EHS&S requirements.
• Primary activities are in the Cleaning Validation area. Performing cleaning Cycle Development, Performance Qualifications, Clean Hold Studies, and Re-Qualification executions.
• Develop MSAT documentation (e.g. protocols, procedures, reports) and co-ordinate MSAT document review and approval.
• Review and approve documents prepared by other MSAT colleagues.
• Field execution of MSAT protocols.
• Liaise with Manufacturing to provide support where required with routine operations / project-based work.
• Compile relevant information from contractors, suppliers, and other departments to develop technical reports.
• Track and resolve exceptions/events/nonconformances during MSAT activities.
• Prioritize MSAT activities in line with Manufacturing / the project schedule.
• Co-ordinate MSAT activities with contractors and vendors as required.
• Attend identified training, required to fulfill the role of a Senior MSAT Engineer.
• Participate in multi-functional teams (project, investigations) as required.

Minimum Qualification

• Degree in Life Sciences, Engineering, Biology, Biochemistry, or related scientific field is required.
• Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.
• Excellent computer proficiency e.g MS Office, Excel, SAP.
• At least 3 yrs experience in the pharmaceutical manufacturing industry or equivalent.
• Must be able to work independently with minimum supervision to meet tight deadlines.

Other Requirements

• Experience in biological Cleaning Validation (Minimum 2 years).
• Also, beneficial would be experience in Projects, Process Validation Support (e.g. Mixing Studies, Microbial Hold Studies, Media Challenges), Thermal Validation, supporting process improvement projects, Supporting New product Introduction/ process validation.
• Ability to interact at different levels of the organization, perform under pressure and handle conflicting interests.
• Ability to work independently under general direction, having a good sense of prioritization of goals and good time management.
• Ability to lead multi-functional team and to manage complexity and change.
• Proven knowledge and application of industry regulations including those of FDA, EMEA, and other authorities.

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

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 and 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 email the Employee Health Support Center ([e-mail]) or contact AskGS to be directed to your accommodation resource.

Preferred Skills

Analytical Reasoning, Computerized Equipment Skills, Emerging Technologies, Gemba Kaizen, Issue Escalation, Lean Supply Chain Management, Problem Solving, Process Control, Process Engineering, Process Oriented, Product Improvements, Science, Technology, Engineering, and Math (STEM) Application, Situational Awareness, Supply Planning, Technical Research, Technologically Savvy, Validation Testing

The anticipated base pay range for this position is :

79,000-120,000

Additional Description For Pay Transparency

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 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 Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits