AmerisourceBergen Specialty Group

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Senior Plant Process Engineer, cGMP

at AmerisourceBergen Specialty Group

Posted: 4/13/2019
Job Status: Full Time
Job Reference #: 00001RQ7
Keywords:

Job Description

• Enhance engineering systems by assisting with the development of detailed equipment configuration files, troubleshooting guides, organized file storage, and continuous improvement procedures.
• Enhance maintenance function by: working with Facilities Engineering Manager to identify gaps in maintenance skill sets, creating and delivering training to maintenance personnel, and ensuring knowledge transfer on technical projects.
• Commission or decommission new or existing equipment across all compounding centers.
• Implement 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 small to medium process automation projects; 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.
• Develop and implement necessary SOPs and training materials; 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.




• BSME or equivalent, Associate Degree in technical field.

• 5 year's progressive experience in process engineering in a GMP or cGMP manufacturing environment, medical device or pharmaceutical.

• 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 process improvements on time, within budget, and meeting specified requirements.
• Experience in aseptic processing preferred.
• Very familiar working knowledge of FDA, GMP, and ISO standards.
• Must be proficient in Microsoft Word, Project, Excel, and Outlook.
• Preference given to experience with Fanuc robots, Allen Bradley PLCs, and AutoCAD.




Qualifications

  • cGMP compounding pharmacy experience
  • Experience in aseptic processing
  • Experience with FANUC robots