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 Manufacturing Associate II, Manufacturing Support Services works in a hands-on capacity in the cGMP production support areas (buffer preparation, equipment cleaning, etc.) to support manufacture of collagenase clostridium histolyticum bulk drug substance (CCH BDS). This role is responsible for the inventory, preparation, and storage of equipment and supplies related to cGMP production and authors and revises SOPs and forms applicable to manufacturing and process equipment documentation. This role supports necessary production and production-related activities, including validation and development work as needed and assists in training new hires and junior team members on production support activities and procedures.
Job Description
Responsibilities
Manufacturing & Compliance
- Performs daily weigh/dispense, buffer preparation, and other process support operations for cGMP manufacture of CCH BDS.
- Ensures work is completed in compliance with approved SOPs, batch records, and controlled documentation and all applicable regulations, guidelines, safety policies and procedures are followed.
- Enters/updates data into compliance documents and computer applications.
- Responsible for the inventory, preparation, and storage of equipment and supplies related to cGMP production.
- Assembles, cleans, and sterilizes production equipment using glassware washers, autoclaves, and CIP technologies.
- Assists with and executes process, equipment, and cleaning validation protocols.
Investigation
- Assists in the resolution of manufacturing deviations/non-conformances.
- Under general supervision, assists with troubleshooting processes and equipment.
Documentation
- Authors and revises SOPs and forms applicable to manufacturing and process equipment documentation.
- Documents work as per SOPs in logbooks, forms, and batch records.
Training
- Assists in training new hires and junior team members on production support activities and procedures.
Qualifications
Education & Experience
- High school diploma is required with a minimum of 3- 5 years working in a pharmaceutical/biopharmaceutical cGMP commercial or late-stage clinical manufacturing environment, OR
- AS degree with 2-4 years’ relevant experience noted above OR
- BS degree with 1-3 years’ relevant experience noted above.
- Experience with CIP, glassware washers, autoclaves, buffer/media preparation, filtration, integrity testers, and aseptic operations.
Knowledge
- Working knowledge of cGMP practices, ICH guidelines, and validation practices.
- Working knowledge of cGMP and equipment cleaning and sterilization practices for biopharmaceutical products.
- General understanding of chromatographic and UF/DF principles.
- Has familiarity with the use of databases.
Skills & Abilities
- Follows schedules and work plans, and coordinates with the Manufacturing group to provide timely support functions.
- Works well with others and establishes working relationships with Quality, Facilities/Engineering/Validation, Process Validation/Development, and Manufacturing.
- Exhibits attention to detail, accuracy in work, and a strong sense of integrity.
- Self-starter, shows willingness to learn and problem-solve.
- Has technical aptitude to learn and operate production equipment.
Physical Requirements
- Ability to stand for long periods of time.
- Ability to wear a sterile gown and shoe covers on a daily basis.
- Ability to wear respirators and other protective equipment for extended periods as required by the task. Ability to lift 40 pounds.
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.