What are the responsibilities and job description for the Process Engineer position at Endo?
Why Endo?
We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.
At Endo, we are building a diverse, equitable and inclusive workplace, and we are looking for talented individuals to join our team.
Job Description Summary
The Process Engineer will be responsible for supporting process engineering initiatives as they pertain to the CCH BDS and other manufacturing process, manufacturing facility, and utility areas. This includes new equipment and / or system installations, and equipment, systems, and process improvement initiatives. Responsible for trouble-shooting, change management, deviations / CAPAs, technical documentation in support of CCH BDS and other manufacturing operations. Responsible for supporting the Horsham site Statistical Process Control (SPC) Program as needed.
Responsibilities
Process Engineering / Manufacturing Operations
- Support process engineering activities associated with the Endo Horsham site and the manufacture of multiple products, including manufacturing equipment upgrades, addition of new equipment, and capital engineering projects. Author change management and other documentation for manufacturing equipment, process, and utilities.
- Assist in troubleshooting manufacturing equipment and assist in completing process deviation investigations / unplanned events. Author, review, and approve cGMP documentation - manufacturing process and equipment deviation investigations, CAPAs, and technical documentation.
- Support process scale-up, development activities, and technology transfer projects.
- Support the Horsham Site Statistical Process Control and Continued Process Verification programs. Utilize statistical control software to analyze and trend process and facility data and results.
- Support the Horsham site validation program - Author / review / approve manufacturing equipment and process validation plans, risk assessments, validation status assessments, protocols, and reports.
- Perform hands-on validation testing including compiling qualification documentation, performing temperature mapping, collecting samples, and other field activities.
- Cross-train with the manufacturing department on cGMP operations including upstream, downstream, and support operations
Qualifications
Education & Experience
Knowledge
Skills & Abilities
Physical Requirements
Commitment to Diversity, Equity, and Inclusion :
At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person’s unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.
EEO Statement :
At Endo, we firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.
