PharMEDium Services, a subsidiary of AmerisourceBergen, is a growing outsource compounding organization servicing hospitals nationwide.
Provide technical skills and expertise in automated equipment design and selection and manufacturing processes improvement and support. Provide technical skills and abilities to assure projects meet schedule and budget commitments. Success is measured through the generation and implementation of projects that meet the desired outcome, budget, timeline, and processing goals. Significant travel is required during equipment commissioning at the various compounding centers. Primary Duties and Responsibilities
Qualifications: Experience and Educational Requirements
- Implementation of new, improved, and/or expanded equipment, tooling, fixturing, and processes for new and existing service offerings. Includes responsibility for defining process requirements, budgeting, design & interfacing with vendors of equipment and tooling, and maintaining appropriate documentation for new equipment and processes including qualification, verification, and validation.
- Manage multiple small to medium process automation projects concurrently; create implementation plans then prioritize activities and closely manage project milestones of assigned projects; identify options and contingencies to keep numerous active projects on track.
- Troubleshoot equipment and processing issues to support compounding operations; determine calibration and maintenance needs of new equipment.
- Develop and implement necessary SOPs; train pharmacists, operators, and maintenance personnel on equipment and SOPs; establish processing, packaging, and test specifications for products and equipment.
- Write, review, and execute validation protocols and reports; perform validations of new automation equipment, processes, water systems, and other process related equipment.
- Provide an engineering-based validation review and input for CAPAs; review technical merits of proposed change control documentation.
- B.S. in Mechanical Engineering or related Engineering field.
- Minimum of 5 years of relevant process engineering experience in medical device and/or pharmaceutical manufacturing.
- Innovative, decisive, results oriented individual contributor with strong problem-solving skills.
- Must possess the ability to work effectively with all levels of organization.
- Must possess excellent interpersonal, communication, and writing skills, ability to analyze technical issues, define/solve problems, establish project plans, statistically evaluate solutions, and draw valid conclusions.
- Demonstrated results in implementing complex automation solutions on time, within budget, and meeting specified requirements.
- Experience in aseptic processing preferred.
- Very familiar with FDA, GMP, and ISO standards.
- Must be proficient in Microsoft Word, Project, Excel, and Outlook.