Location: Rochester,NY, USA
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 I, with guidance, performs various duties related to optimization and analysis of production processes, new products, processes and technology transfers. 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.
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.
* Process Engineering duties within a single location.
* Make decisions within guidelines and policies.
* Follow established procedures to perform assignments, with general instructions on the process and desired outcome.
* Work is reviewed for soundness of technical judgment and accuracy.
* Work is measured by output, meeting and achieving pre-defined monthly/quarterly targets.
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
Accountability
Responsibilities
% of Time
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.
25%
Technical Transfer
* 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.
20%
Formulation Development
* Conduct or assist formulation development and evaluation for marketed and new products.
20%
Troubleshooting
* Troubleshoot the setup and operation of manufacturing/packaging equipment and the process of new R&D projects.
* Conduct or support investigations on deviations.
* Evaluate and troubleshoot basic to mid-level manufacturing / packaging equipment and process issues.
* Work on problems of basic to moderate scope. Follow established practices and procedures in analyzing situations or data from which answers can be readily obtained.
20%
Training
* Conduct training to related department personnel on all technical and project-related documents, such as batch records, protocols, and SOP etc.
15%
Teamwork
* Interact daily with team members and/or functional peer groups, other teams/depts.
* May conduct presentations of technical information.
* Total
100%
Qualifications
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
* BS degree in Engineering or Chemical Engineering preferred with 3+ years' related experience OR
* MS with 1+ year of relevant experience as noted above.
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.
* Working knowledgeable of Current Good Manufacturing Practices (cGMP), FDA, OSHA, EPA, DEA; other regulatory requirements.
* Working knowledge of Pharmaceutical manufacturing principles, practices and applications.
* Analytical test methodology (BU, Assay, CU and dissolution profile, etc.).
* Understanding of concepts of equipment qualification/calibration.
* Understanding of computer validation concepts.
* Basic/Intermediate statistical computations (Cp, Cpk, regression analysis, etc.); use of statistical software.
* Personal computer operations and MS applications (Word, Access, Excel, PowerPoint, MS Project).
* Develops knowledge of principles and concepts of other disciplines.
* Understands the fundamental business drivers for the company.
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.
* 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
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
* Employee is occasionally required to climb or balance; must occasionally lift and/or move up to 50 pounds.
* Employee is frequently exposed to moving mechanical parts, and occasionally exposed to outside weather conditions and risk of electrical shock.
* The noise level in the work environment is usually moderate.
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.