AddressDescription
Johnson & Johnson is hiring for an MSAT Senior Process Engineer - Large Molecule Drug Substance (LM DS)!
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 https://www.jnj.com/.
Are you interested in joining a team that is positively impacting patients' lives by ensuring efficient and effective manufacturing of our pharmaceutical products? Apply now for this exciting chance to join our team!
Manufacturing Science and Technology (MSAT) is responsible for Validation, New Product Introduction (NPI), Lifecycle Management (LCM), Process Improvements, and New Technology Deployment for clinical and commercial products. The MSAT Process Engineer is responsible for supporting site manufacturing activities, product technical transfers, projects, process improvements and changes, and investigations related to clinical and commercial products. It is our responsibility to ensure delivery of MSAT commitments in support of the Malvern site business and MSAT LM DS objectives.
Key Responsibilities:
- Participate in Tech Transfer and NPI Initiatives for the site
- Assist with continuous process verification related to Product Technical Lifecycle Management (LCM) and supporting any commercial product changes
- Provide Technical Assessments to Change Controls/CAPA’s and Deviations
- Author Process Documentation (including manufacturing and validation documents) and complete Study execution
- Drive Innovation and Standardization with a focus on process efficiencies and effectiveness
- Support the department's Inspection Readiness and Execution and represent MSAT in audits and inspections
- Partner with global teams, building cross-functional and cross-site relationships, and exchanging lessons learned
Qualifications
Education:
- Minimum of Bachelor's/University or equivalent degree is required
Experience and Skills:
Required:
- Minimum 2 years of relevant work experience
- Experience within Biopharmaceutical or Pharmaceutical manufacturing industry
- Experience with Product Technology Transfer activities
- Understanding of regulatory requirements and industry guidelines specific for the pharmaceutical industry and validation (e.g., FDA, GMP, ICH, etc.)
- Experience with document management tools and project management tools (such as but not limited to: TruVault or FPX)
- Ability to work effectively with cross-functional teams, manage complexity and change, drive innovation, and collaborate with site and global partners
Preferred:
- Experience with Large Molecules and/or Parenterals
- Problem solving/decision making methodology training including risk-based assessments, FMEAs, and/or Kepner-Tregoe
- Project management experience, training, or certification (e.g., FPX, PMP, or equivalent)
- Lean, Six Sigma, or Process Excellence experience, training, or certification
Other:
- May require up to 10% domestic and international travel
- Requires the ability, through our flexible work policy, to work on-site a minimum of three days each week, with the option for two remote workdays each week
Why join Johnson & Johnson?
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 .
