Engineer, Engineering and Validation Operations
Validation Engineer II, Validation, Michigan-Rochester
About Endo International plc
Endo International plc (NASDAQ: ENDP) is a highly focused generics and specialty branded pharmaceutical company delivering quality medicines to patients in need through excellence in development, manufacturing and commercialization. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in Malvern, PA, employing approximately 3,000 people worldwide. For 2018 Endo, reported revenue of $2.947B and adjusted diluted EPS of $2.89. Learn more at www.endo.com.
The Validation Engineer II evaluates and performs specified validations leading to the accurate and reliable validation of products, processes, equipment, facilities, and systems; assists/performs development of studies/cycles for new processes; helps troubleshoot product problems related to validation; performs testing and documents results for review by site, corporate and government review. Further responsible for providing supporting protocol rationales/justifications for the chosen validation methodology/approach.
Participates in programs to achieve departmental objectives. Records and reports results. Notes unusual results and notifies management for evaluation. Assists with writing validation documents.
In partnership with the site leaders, sponsors a quality and compliance focused site culture which embraces RFT (right first time) and CI (continuous improvement) expectations.
ROLE AND RESPONSIBILITIES:
- Generates validation protocols, and summarizes studies to ensure consistency of data production and compliance with manufacturer and Par Sterile Product’s specifications, with current Good Manufacturing Practices, and national standards
- Responsible for confirming all communicated validation plans to applicable management
- Provides technical assistance in the form of rationales or validation studies to support acceptability of the manufacture of products at Par Sterile Products
- Assists with development of validation protocols, performs testing and writes validation reports for various equipment/processes pertaining to manufacturing area.
- Helps to determine process capability of new equipment though execution of approved protocols and assures that defined parameters are incorporated into respective operating procedures
- Responsible for effectively adopting modern validation techniques, current industry practices, risk management principles, science-based approaches and a strong understanding of process
- Troubleshoots and resolves issues as needed
- Capable of providing reliable direction to Level I Validation Engineers concerning protocol execution practices and on the floor issues.
- Interacts with outside testing laboratories and provides validation assistance where needed on specific validation issues
Production Process Qualification
- Responsible for the performance qualification of production processes, and writes process validation protocols and final report packages
- Generates, executes and summaries Product Process Qualification for the entire scope of the production processes
- Comprehensive understanding of all production processing steps and thorough knowledge of required validations
- Provides validation input at team meetings for various projects
- Capable of managing multiple projects while adhering to project deadlines
- Performs special projects as assigned by department management
- Conducts deviation investigations
- Evaluates equipment or process problems and designs testing to determine possible causes or solutions.
- Establish and maintain effective cross functional relationships
- Issues data, memos and reports concerning validations projects
- Analyze data and generate reports
Standard Operating Procedures
- Adheres to all company and cGMP procedures, along with safety regulations within the plant
Education & Experience
- Bachelor of Science in Engineering or Science discipline preferred
- Four (4) to six (6) years of combined experience in pharmaceutical (i.e. Validation/QA or R&D), medical device, biotechnology industries or equivalent combination of education and experience
- Proficient in Microsoft Word, Excel, Power Point, Project and other software relevant to the performance of the job
Skills & Abilities
- 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.
- Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
- 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.
- Diversity - Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; educates others on the value of diversity; promotes a harassment-free environment; Builds a diverse workforce.
- Ethics - Treats people with respect; Keeps commitments; inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
- 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.
- Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.
- Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
- Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.
- Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.
- Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.
- Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals. Completes tasks on time or notifies appropriate person with an alternate plan.
- Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.
- Talk or hear
- Wet or Humid
- Work near moving mechanical parts
- Fumes or airborne particles
- Afternoon shift premium is 10% (non-union positions only)
- Midnight shift premium is 15% (non-union positions only)
Endo recognizes the advantages of a diverse workforce achieved through a commitment to equal employment opportunities.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled