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We are currently seeking a highly qualified individual to join our Quality team as a Quality Assurance, C&Q Specialist at our new Large Molecule Drug Substance Manufacturing facility in Wilson, North Carolina. We are seeking a talented and passionate professional who thrives in a fast-paced environment and is committed to ensuring the highest standards of quality throughout our organization. If you have a keen eye for detail, exceptional problem-solving skills, and a proven track record in quality assurance, this is the perfect opportunity for you to make a lasting impact.

As Quality Assurance, C&Q Specialist, you will be responsible for ensuring compliance with regulatory requirements and company policies while overseeing commissioning, qualification, and validation activities for equipment, utilities, and facilities following current Good Manufacturing Practices, Johnson & Johnson Policies and internal procedures to ensure compliance with regulatory requirements and industry standards supporting project and commercial stages of the new Site.

Essential Job Duties and Responsibilities:

• Ensure the site validation program has been developed and maintained in compliance with all regulatory and corporate requirements and Master Plans.
• Works with the applicable qualification teams representing Quality Assurance in the requirement, design review, construction, qualification and leveraging documentation strategies, cleaning development/validation and implementation of project.
• Review and approve commissioning and qualification documentation, including URS (User Requirements Specifications), IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols and reports, SOP's, Work Instructions and any other technical document.
• Review and approves validation protocols and reports (analytical, cleaning, process, etc.)
• Provide quality oversight for C&Q and validation execution activities to ensure compliance with GMP, FDA, EMA, and other regulatory requirements.
• Support the development and implementation of C&Q and validation plans, ensuring alignment with project timelines and deliverables.
• Participate in the risk assessment process for equipment, utilities, and systems to define qualification/validation requirements.
• Perform QA reviews of system impact assessments and categorization of equipment and utilities.
• Ensure compliance with company quality standards, including SOPs, work instructions, and quality policies.
• Act as the QA point of contact for deviations, CAPAs, and change controls related to C&Q and validation activities.
• Provide recommendations for process improvements to enhance compliance and efficiency in C&Q and validation activities.
• Reviews/approves Technology Transfer documents assuring they meet regulatory and J&J requirements.
• Collaborate with cross-functional teams, including engineering, validation, and manufacturing, to address quality issues.

Qualifications

Required:

• Bachelor's degree in a scientific or engineering discipline is required.
• A minimum of 4 years of work experience within the biological and/or pharmaceutical industry and knowledge in compliance of commissioning, qualification and validation of GMP processes and systems.
• Strong understanding of cGMP, FDA, EMA, ICH guidelines, and ISPE Baseline Guides. Hands-on experience with qualification/validation lifecycle (URS, FAT, SAT, IQ, OQ, PQ) and cleaning/process validation.
• Familiarity with ISPE guidelines, including GAMP 5, ASTM E2500, and validation lifecycle principles.
• Strong understanding of risk-based approaches to commissioning and qualification/validation.
• Proficiency in technical writing for validation and quality documents.
• Strong communication and interpersonal skills for cross-functional collaboration.
• Proven expertise as a Subject Matter Expert in C&Q for regulated industries.
• Proficiency in risk management methodologies such as FMEA and HACCP.

Preferred:

• Knowledge working with utilities (water for injection, clean steam, process gases, HVAC, SIP/CIP), fridges, freezers, LAF, BSC units, autoclaves and isolators - as well as Process Equipment - Bioreactors, UF/DF, centrifuge, Chromatography systems.
• Experience in development/and or evolution of C&Q strategies and/or start up experience highly desirable.
• An unquestionable level of integrity and commitment to operating ethically and within the boundaries of regulatory requirements.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.
• Proven ability to manage multiple priorities and work independently with minimal supervision.
• Detail-oriented mindset, with a keen eye for identifying opportunities for process improvements.
• Proven ability to prioritize tasks and meet deadlines in a dynamic manufacturing environment.
• Ability to build and nurture strong and positive relationships.
• The ability to work in a team environment and interact with all levels of the organization.

Note: This position description is a general guideline; it does not purport to be an exhaustive list of all elements of the position. Management reserves the right to modify this position description at any time, or to vary the duties and responsibilities of the position to meet production, scheduling or other business needs.

If you are passionate about quality, GMP, qualification/validation in the biotech/pharmaceutical industry and possess the necessary skills and experience, we invite you to apply for this exciting opportunity as a C&Q QA Specialist. Join our team and contribute to the development of life-saving therapies in a dynamic and rewarding environment.

The anticipated base pay range for this position is $91,000 to $147,200. The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

This job posting is anticipated to close on 12/31/2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

• Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
• Holiday pay, including Floating Holidays - up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year

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

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.