Process Engineer II - Bioprocess Technical Operations

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 II, under general direction, performs various duties related to optimization and analysis of production processes, new products and processes, and technology transfers. Provides support for troubleshooting and improvements to existing products and processes. Prepare and execute engineering study protocols, manufacturing and packaging experimental / feasibility study / validation batch records and protocols and complete interim and / or final summary reports for marketed and new products. Perform or assist on-site and site-change technical transfer, scale-up or scale-down factor evaluation, manufacturing / packaging process and equipment troubleshooting, and SOP preparation and review. Create product and consumables specifications for new and existing products and processes.

Job Description

Responsibilities:

Validation Protocols

• Prepare and execute engineering study protocols, manufacturing and packaging experimental / feasibility study / validation batch records and protocols and complete interim and / or final summary reports for marketed and new products.
• Coordinate with Facilities, Engineering, Manufacturing, Packaging, Product Development, Analytical Services, RA, and QA to initiate manufacturing and packaging experimental / feasibility study / validation projects for marketed and new products.

Technical Transfer

• Perform on-site and site-change technical transfer, scale-up or scale-down factor evaluation, manufacturing / packaging process and equipment troubleshooting, and SOP preparation and review.

Laboratory Development

• Conduct formulation development and evaluation for marketed and new products.
• Execute small scale scouting/experimental/feasibility studies to support new and current products and process changes.

Troubleshooting

• Troubleshoot the setup and operation of manufacturing/packaging equipment and the process of new R&D projects.
• Conduct investigations on deviations.
• Evaluate and troubleshoot mid to high level manufacturing / packaging equipment and process issues.
• Work on problems of increasing complexity where analysis of situation or data requires review of identifiable factors.  Recommend solutions to technical issues.

Training

• Conduct training to related department personnel on all technical and project-related documents, such as batch records, protocols, and SOP etc.

Teamwork

• Frequently interact with team members, supervisors, outside customers/vendors, & other teams/departments. Interaction normally requires the ability to gain cooperation of other departments, conducting presentations of technical information concerning specific projects/schedules, etc.

Qualifications:

Education & Experience

• BS degree in Engineering or Chemical Engineering preferred with 5+ years’ related experience OR MS with 3+ years’ experience as noted above OR PhD with 0-1 year of experience as noted above.

Knowledge

• Knowledgeable of Current Good Manufacturing Practices (cGMP), FDA, OSHA, EPA, DEA; other regulatory requirements.
• Pharmaceuticals manufacturing principles, practices and applications.
• Working knowledge of Analytical test methodology (BU, Assay, CU and dissolution profile, etc.).
• Understanding of concepts of equipment qualification/calibration.
• Understanding of computer validation concepts.
• Intermediate statistical computations (Cp, Cpk, regression analysis, etc.); use of statistical software.
• Personal computer operations and MS applications (Word, Access, Excel, PowerPoint, MS Project).
• Has general working knowledge of principles and concepts of other disciplines within own function.
• Contributes to the development of new concepts, techniques and approaches.

Skills & Abilities

• Is able to write clearly and succinctly for the technical community and can construct logical arguments well.
• Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
• Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
• Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.
• Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
• Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity.
• Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.
• Innovation - Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention.

Physical Requirements

• Employee is occasionally required to climb or balance; must occasionally lift and/or move up to 50 pounds.
• The noise level in the work environment is usually moderate.
• Employee may need to travel for business upon determination of project requirements and need.

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.