Description

Responsibilities

Manufacturing & Compliance

• Performs and supports fermentation process scale-up, cGMP manufacture and validation.
• Works in a hands-on capacity to operate fermenters, perform seed scale-up, sterilize equipment, prepare media solutions, and clean equipment as required.
• 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.
• Working knowledge of SAP and process order requirements, ability to adjust as needed
• Supports validation efforts and assists in the authoring and implements change controls associated with fermentation manufacturing equipment, processes and utilities.

Training

Trains other Manufacturing Associates

Documentation

Authors, revises, and reviews manufacturing and process equipment documentation.

Investigation

• Authors investigations and assists in the resolution of manufacturing deviations / non-conformances.
• Troubleshoots processes and equipment and assists with process, sterilization, and cleaning validation initiatives.

Qualifications

Education & Experience

• High school diploma is required with a minimum of 4 years working in a pharmaceutical / biopharmaceutical cGMP manufacturing environment, technology development, technology transfer, validation, OR
• BS degree in Biological Sciences or Bioengineering with 2 years’ relevant experience
• Strong background in fermentation and process scale-up of proteins and enzymes is required.

Knowledge

• Strong knowledge of cGMP practices, ICH guidelines, and validation practices.
• Strong knowledge of automated or semi-automated fermenters, bioreactors, holding tanks, aseptic operations, seed scale-up, harvest equipment, and cleaning and sterilization procedures for biopharmaceutical products.
• Strong knowledge of process validation practices for biopharmaceutical products.

Skills & Abilities

• Demonstrated ability to resolve equipment and process problems and plan daily activities for self and resolve problems in area of expertise.
• Works well with others and establishes working relationships with Quality, Facilities / Engineering / Validation, Process Validation / Development, and Manufacturing Validation / Development, and Manufacturing.
• Exhibits open and constructive communication style based on the need of the receiver and by using the appropriate communication method.
• Exhibits attention to detail, accuracy in work, and integrity of character.
• Innovative and efficient when solving problems and considers possible implications of the decisions made.
• Has technical aptitude to learn and operate production equipment.

Physical Requirements

• Ability to work in a clean room environment.
• Ability to stand for long periods of time.
• Ability to wear a sterile gown and don shoe covers on a daily basis.
• 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.

Last updated : 2024-06-03