Job Description

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 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.

Job Description

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

• Bachelor’s degree in chemical, Biochemical, or Biological Engineering or equivalence in related experience
• Minimum 3 years’ experience working in a cGMP biopharmaceutical manufacturing environment, Process Engineering, Equipment and Process Validation and Maintenance, and/or Manufacturing Technology/Technology Transfer
• Solid background in fermentation and process scale-up of microbial proteins and enzyme production

Knowledge

• Thorough technical knowledge of automated or semi-automated fermenters, sterilization techniques/SIP, autoclaves, and aseptic techniques.
• Knowledge of GMP critical systems like HVAC, WFI, Clean steam, CIP and SIP.
• Firm understanding of industry standard practices for biopharmaceutical production with respect to GMP systems and documentation.
• Good understanding and experience in systems and equipment validation, writing, executing, and reviewing validation protocols and technical documentation.
• Experience with statistical control software (SAS-JMP, SPSS, R, MATLAB, Minitab) is a plus

Skills & Abilities

• Solid technical writing skills.
• Clear communicator, both verbally and written, to subordinates and peers.
• Customer-service focused individual with the ability to “roll-up sleeves”
• Works well with others and establishes working relationships with Manufacturing, Quality, Facilities and Engineering, and Manufacturing Technology/Biotechnology Operations
• Ability to troubleshoot process and equipment issues. Innovative and efficient when solving problems, considers possible implications of the decisions made.

Physical Requirements

• This position may require working with or around hazardous substances, and may be subject to work restrictions and precautions as set forth in the Safety Data Sheet, provided to all affected employees
• Travel (10%), Lifting, Physical Constraints

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.

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