Experienced Engineer Process Engineering- Thermal Validation
Johnson & Johnson Innovative Medicine
Summary
Johnson & Johnson is currently seeking an Experienced Engineer - Thermal to join our Manufacturing Science and Technology team located in Wilson, NC.
Job description
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
- Conduct MSAT activities in compliance with US and EU regulations, JBI procedures and EHS&S requirements.
- Perform autoclave Cycle Development, Performance Qualifications, Controlled Temperature Equipment (refrigerators/freezers) and Re-Qualification executions.
- Develop MSAT documentation (e.g. strategies, plans, 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.
- Represent the JBI MSAT site team on platform technical teams.
- Prepare reports for completed protocols for review and approval.
- Initiate and implement change control activities in accordance with site procedures.
- Track and resolve exceptions/events/nonconformances during MSAT activities.
- Prioritize MSAT activities in line with Manufacturing / the particular 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.
- Secondary activities include Process Validation Support (e.g. Mixing Studies, Microbial Hold Studies, Media Challenges), Cleaning Validation, supporting process improvement projects, Supporting New product Introduction/process validation, GMP documentation generation (e.g. protocols / SOPs / WIs / Technical Documents, Exception/Event Investigations).
Requirements
- 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.
- Experience in biological Thermal Validation (Minimum 2 years).
- The 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 teams and to manage complexity and change.
- Proven knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.
Benefits
- Vacation
- Sick time
- Holiday pay
- Floating holidays
- Work, personal and family time
- Parental leave
- Condolence leave
- Caregiver leave
- Volunteer leave
- Military spouse time-off
Company overview
Johnson & Johnson Innovative Medicine is the pharmaceutical division of Johnson & Johnson, leading the way in medical innovation with a relentless focus on bringing transformational treatments to patients worldwide. The company applies rigorous science and compassion to address the most complex diseases of our time, developing groundbreaking medicines across key therapeutic areas including oncology, immunology, neuroscience, and cardiopulmonary medicine. With deep expertise and global reach, Johnson & Johnson Innovative Medicine reimagines how devastating diseases are treated and cured, delivering hope and better care for millions of patients and their families. The organization pioneers the path from laboratory research to clinical application, championing patients every step of the way while maintaining an unwavering commitment to scientific excellence and patient-centered innovation.