Position Summary

The Process Engineer role is assigned to lead BioTissue’s process engineering activities, including the process scale-up and technology transfer from R&D to commercial production, as well as process optimization of various areas within the Operations department. A solid understanding of GMP requirements and Quality Systems is required. The ability to support regulatory submissions and to represent BioTissue in inspections by national and international health authorities is essential for this position. The position holder enjoys the responsibility and accountability that comes with being part of a small team of engineers, technicians, and scientists. Team leadership, innovative thinking, cross-functional communication, and support of other divisions within our rapidly growing business are substantial requirements. Additional responsibilities include, but are not limited to, the management of the instrumentation and calibration program as well as the operation of control systems, such as BMS, PAS, and individual PLCs.

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Essential Duties & Responsibilities

• Provides Subject Matter Expertise, direction, and guidance on assigned areas of process engineering, including but not limited to the definition of user requirement specifications, conducting feasibility studies, design, engineering, and project management.
• Initiates and completes process improvement projects.
• Works in multiple areas of process improvement.
• Contributes to BioTissue’s success as a subject matter expert in various expansion projects.
• Lead technology transfer efforts from R&D to commercial scale.
• Supports production equipment and processes as needed.
• Responsible for oversight and operation of Building Management Systems, Process Automation Systems, and PLCs.
• Supports writing of user requirements specifications, commissioning, IQ, OQ, and PQ for new equipment, re-qualifications, and retrospective qualifications.
• Supports diagnosis of technical malfunctions and subsequent repair or replacement if needed.
• Provides input to all quality system-related actions such as non-conformance reports, change controls and CAPAs.
• Operates with the highest level of integrity and ethical performance. Has a focus on detail and expects the same from internal and external business partners.
• Provides, as necessary, “hands-on” troubleshooting and active support to the Facilities Maintenance Team.
• Works cross-functionally with other divisions within the Facilities and Engineering Team.
• Supports regulatory submissions as the subject matter expert for process-related content.
• Other duties as assigned.

Skills & Abilities

Essential Duty Definition:

• Ability to represent BioTissue in inspections by national and international health authorities.
• Has the ability to translate complex technical issues into simpler terms that can be understood by a wider audience.
• Excellent communication skills; fluent (oral/written) English.
• Strong conceptual, analytical, and problem-solving ability.
• Well-developed team skills. Equally effective as a team lead, team member, and individual contributor.
• Excellent organizational skills
• Working knowledge of AutoCAD is desired.
• Ability to multitask, setting priorities effectively to produce quality work in a fast-paced professional environment
• Proficient in Microsoft software applications: Excel, Word, PowerPoint, and Outlook.

Position Expertise/Qualifications

• Bachelor's degree in science or engineering, required.
• 2 years’ experience in the following, required:
  1. GMP regulated environment with a track record of accomplishments
  2. Process development, technical qualification, process validation, instrumentation, calibration, automation and maintenance management

Physical Requirements

• Sedentary work that generally requires sitting and/or standing