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Manufacturing Associate I, Manufacturing Support…
- Endo International (Horsham, PA)
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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.
Job Description Summary
The Manufacturing Associate I, 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 supporting necessary production and production-related activities, including validation and development work as needed.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Job Description
Responsibilities:
Manufacturing & Compliance
+ Performs daily weigh/dispense, buffer preparation, and other process support operations for cGMP manufacture of CCH BDS.
+ Works in a hands-on capacity to prepare buffers for purification and fermentation production steps as per manufacturing schedules.
+ Enters/updates data into compliance documents and computer applications.
+ Assists with process, equipment, and cleaning validation protocols.
Investigation
+ Assists in the resolution of manufacturing deviations/non-conformances.
+ Under direct supervision, assists with troubleshooting processes and equipment.
Qualifications:
Education & Experience
+ High school diploma is required with 0-1 year working in a pharmaceutical /biopharmaceutical cGMP commercial or late-stage clinical manufacturing environment.
Knowledge
+ General knowledge of cGMP practices, ICH guidelines, and validation practices.
+ General knowledge of chromatographic and UF/DF principles.
Skills & Abilities
+ Follows schedules and work plans, and coordinates with manufacturing groups to provide timely support.
+ 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 integrity of character.
+ 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.
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.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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