Automation Engineer

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 Automation Engineer is responsible for supporting ongoing manufacturing processes, developing/designing manufacturing processes for new products, and ensuring effective communication and coordination between all participating departments. The Engineer plans and conducts small to medium sized projects requiring conventional types of plans, investigations, and equipment. Assignments include system, equipment or process design and development; equipment start-up, construction site responsibilities; preparation of specs or bid packages; regulatory and safety compliance. The Engineer’s primary objective is to ensure that manufacturing processes are capable, compliant, in control, and continuously improved.

Job Description

Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.

Assigned U.S. based manufacturing site.

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Responsibilities

% of Time

Manufacturing Process Development

• Interfaces with R&D, technical operations, manufacturing, packaging, purchasing, and quality departments to design efficient and reliable manufacturing processes.
• Generates change controls to introduce new or modify existing equipment/systems.
• Develops and executes equipment and system qualification protocols to ensure compliance and adherence to cGMP and Company standards.
• Executes engineering studies related to in-process testing (e.g. net weight verification, seal integrity verification).
• Creates and updates standard operating procedures for setup, operation and cleaning of equipment.
• Works closely with manufacturers and suppliers to ensure equipment, systems, tooling, and components meet Company needs.
• Attends FATs (Factory Acceptance Tests) to verify equipment operates in accordance with cGMP and Company standards.
• Maintains process knowledge and ownership.
• May lead or participate in cross functional initiatives.
• Provides technical support and analysis for the resolution of deviations, investigations, and process issues.
• Assists in authoring manufacturing batch records.
• Organizes equipment and system training sessions for mechanics and operators.

80%

Manufacturing Process Improvement

• Evaluates, selects, and applies standard engineering techniques, procedures, and criteria to improve quality, safety, efficiency, and waste reduction.

20%

Total

100%

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and  certifications required for the job

• Bachelor of Science or Master of Science degree in Chemical, Mechanical, or Electrical Engineering or related studies required with 2-5 years’ progressive technical experience.
• Previous experience in cGMP manufacturing environment.
• Pharmaceutical industry experience a plus.
• Relevant college/university Internships.

Knowledge

Proficiency in a body of information required for the job    

e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

• Strong knowledge of 2D and 3D design software (e.g. AutoCAD, SolidWorks).
• Knowledge of cGMP and FDA regulations.
• General understanding of Lean Manufacturing and Six Sigma principles.

Skills

&

Abilities

Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.

• Proficient with Microsoft software (e.g. Word, Excel, Project, PowerPoint, Outlook, Visio).
• Must have the ability to work effectively with a computerized maintenance management system and instruct others on its operation.
• Able to establish and maintain cooperative working relationship with individuals contacted in the course of work.
• Able to understand and follow oral and written instructions.
• Able to communicate clearly and concisely, both oral and writing.
• Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures.
• 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.
• Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
• Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.
• Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.

Physical Requirements

Physical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

• Occasionally be required to climb or balance.
• Occasionally be required to lift and/or move up to 50 pounds.
• Occasionally exposed to outside weather conditions and risk of electrical shock.
• May be exposed to high noise environments.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.

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.