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 Operations Engineer, Sterile Filling, works in a hands-on capacity in a fast-paced, cGMP environment and production support areas to process sterile and aseptic products. The specialist works in collaboration with Operations, Maintenance, Engineering, Supply Chain, Quality Assurance, and Pharmaceutical Technology and Validation for successful repeatable day-to-day manufacturing operations in the Sterile Filling Area.
Position is responsible for working with operations team to mitigate gaps within the sterile filling operations. Position also facilitates maintaining departmental documentation and processing of batch documentation. Position is also trained to perform verification of process steps in support of departmental supervision. Knowledge of cGMP’s is essential to successful performance of the position. 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.
Primary focus is to assure proper use and function of automated technology with complex operating systems, electronic interfaces, and validated data collection systems. The role works within manufacturing ensuring operational up-time, continuous improvement and innovation; leads production personnel throughout operations set-up, troubleshooting, and personnel training. During active operation, Off-shift or weekend coverage occasionally required to support the production schedule, technical team, or project-specific assignments.
Collaboration occurs within team framework and cross functional teams of dedicated specialists who strive to understand, monitor, improve and support manufacturing processes throughout the facility. While focus is on day-to-day activities, there are opportunities to support strategic projects. The overall team ensures the facilities operate Right-First Time in a cost-effective manner, with on-going operational activities, and meeting the financial/timeline requirements. This role requires daily problem solving with other Technical groups, Maintenance, Validation, Operations, and Quality as well as equipment manufacturers and suppliers. A well-qualified candidate must have good analytical, trouble-shooting, problem solving, and communication skills; authors and revises manufacturing and process equipment documentation and is responsible for supporting validation and development work.
Specialist must qualify the company Aseptic gowning and process requirements and maintain this qualification annually for the position.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Job Description
Scope of Authority
-
Key Accountabilities
Operational Engineering
- Participates in the design, development, and implementation of methods and systems to ensure process control, product quality, and process improvement opportunities.
- Leads production personnel throughout set up, troubleshooting, and personnel training; monitors production.
- Drives production pace, reduction in downtime; addresses sterile filling equipment related problems that may result in yield losses, product or material waste
- Supports work completion in compliance with approved SOPs, SAP transactions, batch records, KPIs and controlled documentation and all applicable regulations, guidelines, safety policies and procedures are followed.
- Maintains departmental documentation such as eLUMAC, current SOP’s and Work Instructions and other forms.
- On occasion, schedule and train union colleagues for more efficient performance in their assignment and creates an atmosphere of team effort and open communication. Participates in the design of department training programs and assures that all colleagues receive proper orientation and training.
- Assures department is compliant with all procedures, GMP regulations, safety, and contract obligations. Assists in addressing and closing incident and deviation investigations, CAPA’s, PPM’s, GMP Tasks and Change Controls as required.
- Accountable for delivering on Rochester manufacturing and departmental objectives
- Accountable for providing technical support to manufacturing operations
- Lead/Assist technical and business system process improvement projects
- Establishes and collaborates in working relationships with Quality, Facilities/Engineering/Validation, Process Validation/Development, and Manufacturing
60%
Quality Management System
- Conducts, supports, authors investigations and change controls with respect to equipment functionality, recipes, parameters, and operational events
- Assists with process and equipment qualification/validation
- Authors SOPs, work instructions, training guides, set up guides, and technical documentation for optimized operational performance and process equipment
- Participates in training programs, trains new colleagues on equipment
40%
Safety and Compliance
- Observes all company Procedures and Safety and Health Regulations
- Performs all functions in accordance with current Good Manufacturing Practices
Continuous
Total
100%
Qualifications
Education & Experience
- BS degree with 1-3 years’ relevant pharmaceutical experience.
- Experience with electronic systems, sterilization cycle, automation equipment/recipes, preferred.
- Bachelor’s Degree or higher in Engineering or Science related equivalent, preferred.
Knowledge
- Knowledge in cGMP practices, ICH guidelines, and validation practices
- Knowledge in Lean Six Sigma practices and methods, data analysis
- Knowledge of aseptic processing operations
- Microsoft Office Suite, Quality Management Systems (QMS: Trackwise, LMS, LIMS), Enterprise Resource Planning (ERP) Systems, Calibration Maintenance Management Systems (CMMS).
Skills
&
Abilities
- Demonstrated ability to troubleshoot and resolve equipment and processing issues; has technical aptitude to learn and operate production equipment.
- Ability to perform aseptic gowning during the execution of job duties
- Strong leadership, interpersonal and communication skills (written and oral) are required
Relevant competencies:
- 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.
- 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.
- 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.
- Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs and intended audience; 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
- Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures
- Ethics - Treats people with respect; Keeps commitments; inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
- Design -Generates creative solutions; Translates concepts and information into images; Uses feedback to modify designs; Applies design principles; Demonstrates attention to detail.
- 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.
- 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/accountability for own actions; Follows through on commitments.
- 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.
- Resilience - Deals effectively with pressure, remains optimistic and persistent even under adversity. Recovers quickly from set-backs.
- 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.
- 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.
- 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.
- Required to reach with hands and arms; frequently required to use hands to finger, handle or feel.
- Occasionally lift and/or move up to 50 pounds
- Specific vision abilities required by this job include close vision.
- Frequently exposed to moving mechanical parts
- Frequently exposed to toxic or caustic chemicals
- Ability to stand for long periods of time
- The noise level is moderate
- Work environment is a production/manufacturing environment
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.
