Packaging Engineer, Supply Chain Administration, 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 Engineer, Packaging plans, conducts, and completes package engineering assignments to develop or revise packaging processes, packaging components, labeling, material specifications, and Bill of Materials for sterile pharmaceutical products. Works with package material, component, and equipment suppliers to identify and implement new technologies to improve package performance, process efficiencies, and reduce costs. Works closely with multiple internal departments across multiple sites to address and resolve packaging issues. Provides package engineering services to contract customers.
ROLE AND RESPONSIBILITIES:
Package Design & Development
- Conducts the design, development, engineering, and implementation of packages and packaging processes for sterile pharmaceutical products, including, but not limited to the following sterile container/closure systems: vial, ophthalmic, and prefilled syringe
- Write and execute packaging instructions, packaging engineering studies, protocols, and line trials
- Write package material and component specifications, package Bill of Materials, and packaging process instructions for new and existing Par and contract customer products
- Review and approve packaging artwork and proofs for mechanical correctness
- Provide packaging development and engineering support as a service to contract customers. Provide package alternatives to contract customers where their existing primary and secondary packages are incompatible with filling and packaging lines
- Develop component cost estimates and other data, as required. Recommend economical alternatives consistent with high quality standards
- Investigate complaints relating to packaging materials and designs, and develop solutions to packaging problems
- Identify alternate suppliers, as appropriate
- Responsible for observing safe operating procedures and established safety rules, coordinate resources to provide appropriate safety training for themselves and their work force, and follow safety procedures consistent with applicable rules and standards
- Comply with the company change control procedures to ensure that only approved packaging materials and processes are used. Comply with all company procedures as required by the position
- Maintain awareness of all government regulations as they pertain to packaging materials, components, processes, and products
- Assist in developing automation projects to improve both production needs and documentation flow
Education & Experience
- Bachelor of Science Degree in Package Engineering, Packaging Science and/or related field
- 2-4 years of related experience
- Knowledge of 21 Code of Federal Regulations, Parts 210 and 211, cGMP’s, and other applicable FDA Regulatory requirements
- Knowledge of U.S., Japanese, and European Compendia requirements as they pertain to packaging materials, components, processes, and products
- Knowledge of parenteral drug packaging desired
Skills & Abilities
- Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures.
- Design - Generates creative solutions; Translates concepts and information into images; Uses feedback to modify designs; Applies design principles; Demonstrates attention to detail.
- 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.
- Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.
- 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.
- Visionary Leadership - Displays passion and optimism; Inspires respect and trust; mobilizes others to fulfill the vision; Provides vision and inspiration to peers and subordinates.
- Change Management - Develops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Prepares and supports those affected by change; Monitors transition and evaluates results.
- Leadership - Exhibits confidence in self and others; Inspires and motivates others to perform well; effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others.
- Quality Management - Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.
- Business Acumen - Understands business implications of decisions; Displays orientation to profitability; Demonstrates knowledge of market and competition; Aligns work with strategic goals.
- Cost Consciousness - Works within approved budget; Develops and implements cost saving measures; Contributes to profits and revenue; Conserves organizational resources.
- 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.
- Strategic Thinking - Develops strategies to achieve organizational goals; Understands organization's strengths & weaknesses; Analyzes market and competition; Identifies external threats and opportunities; Adapts strategy to changing conditions.
- Judgment - Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
- Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals.
- 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.
- 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.
- 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.
- 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.
- 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.
- Able to sit and stand for up to 8 hours
- Able to walk through production areas, across plant/warehouse, across campus
- Able to lift up to 30 pounds
- Business Travel: Up to 10%
Endo recognizes the advantages of a diverse workforce achieved through a commitment to equal employment opportunities.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled