The Process Engineer will be involved with all the elements involved in producing a particular product within the manufacturing Value Stream Organization (VSO). This involves overseeing the efficiency and safety of current manufacturing processes, as well as developing new processes to improve manufacturing efficiency or decrease its costs. The incumbent will interact with internal customers to provide technical support during process development, scale-up, technology transfer, validation and commercialization; support supply chain working to assure uninterrupted product supply.
Scope of Authority
Must gain approval to spend, limited scope of authority
- Problem Solving (50%)
- Investigate and resolve production problems.
- Determine root causes of failures using problem solving and statistical methods and recommend changes in designs, tolerances, or processing methods.
- Investigate or resolve operational problems such as occurrences, deviations, process investigations and customer complaints.
- Breakthrough thinking (10%)
- Identify opportunities or implement changes to improve products and processes or reduce costs using knowledge of manufacturing processes, tooling and production equipment, packaging methods, quality control standards or product design, materials and parts; provide technical risk assessments and justification documents.
- Customer Focus (5%)
- Provide technical process support and expertise for the scale up and/or transfer in of new products and/or process changes due to materials, equipment, or other environmental factors.
- Continuous Improvement (5%)
- Apply continuous improvement methods such as lean manufacturing to enhance manufacturing quality, reliability, or cost effectiveness.
- Participate in site-wide priorities and lean initiatives using the DMAIC.
- Change Management (5%)
- Coordinate, conduct and evaluate experiments and trial production batches for material changes (packaging components, APIs, and excipients).
- Documentation (5%)
- Prepare documentation for new manufacturing processes and qualification and validation activities.
- Reporting (5%)
- Prepare reports summarizing information or trends related to process performance.
- Collaboration (5%)
- Manage as well as participate in manufacturing and project teams; interact with peers at Endo including supply chain, QA, RA, R&D, and project management, and third party manufacturers to insure reliable commercial supply and advance projects in a timely and cost effective way while maintaining quality.
- Technical Operations (5%)
- Work with ANDA and NDA Technical Operations to ensure manufacturability of new products as they advance through process development, scale-up, technology transfer, validation, and commercialization.
- Metrics (5%)
- Participate in budget planning and financial assessments. Perform cost of goods calculations and make recommendations based on the business objectives.
- Other duties as assigned by manager
Education & Experience
- BS in Chemical Engineering, Chemistry, Pharmacy or related scientific field with a minimum of 8 years relevant experience in the pharmaceutical industry or related field.
- Lean Six Sigma Black Belt a plus
Skills & Abilities
- Familiarity with cGMP, DEA, OSHA, and FDA regulations as well as, SUPAC and ICH guidelines.
- Understanding of the current pharmaceutical technologies and manufacturing equipment ; technology transfer and scale-up, testing, validation, and packaging.
- Knowledge of requirements for post approval changes, relevant ICH, SUPAC and current process validation guidance needed. Knowledge and Understanding of formulation development of solid/liquid dosage forms a plus.
- Process development, technology transfer and scale-up, technical writing, strong communication skills, and analytical thinking and problem solving. Risk assessment and statistical process control a plus.
- Position requires an understanding and experience with pharmaceutical manufacturing processes and equipment. Sound experience of various solid oral dosage formulations is desirable.
- Experience implementing and evaluating contracted work with vendors and suppliers and maintaining successful partnerships.
- Able to work well in a team-oriented environment
- Able to organize, prioritize, and successfully complete multiple projects, tasks, and issues in a timely manner.
- Able to sit or stand for up to 8 hours.
- Able to work in a manufacturing environment
- Able to lift up to 20 lbs.
Endo Pharmaceuticals - 21 months ago
Endo Health Solutions, formerly known as Endo Pharmaceuticals, wants the pain to end, preferably through the drugs it acquires and markets....