Electronic Batch Records Design Specialist

Scorpion Therapeutics; Michigan; On-site; USD 60,000 - 90,000; Full time

Job summary

Scorpion Therapeutics seeks an experienced EBR/ MES specialist to design, revise, and support electronic batch records. You will drive change controls, assist end users, and coordinate with cross-functional teams to ensure accurate parameter capture and compliant documentation.

Responsibilities include process mapping, protocol verification, and continuous improvement of batch record workflows within a GMP/GDP environment. Collaboration with SMEs and operators is essential for success.

Qualifications

• Bachelor’s, Associate’s, or High School diploma in a relevant field
• Pharmaceutical experience required
• Certifications: M1, Yellow Belt and/or Pfizer Human Performance methodologies
• Computer skills: HTML, Java, or object-oriented programming
• Focused in systems Analyst / data management
• EBR / MES build experience
• Experience with Quality Tracking Systems

Responsibilities

• Design, prepare, and revise Electronic Batch Records (EBR).
• Support end users with EBR execution and usage.
• Manage EBR design/configuration changes and process reviews.
• Initiate and own change controls for documents and equipment; ensure timely closure and implementation.
• Participate in process mapping with SMEs, leads, and operators.
• Serve as sustainment point of contact for electronic batch record manufacturing issues.
• Execute functional verification protocols for MES/recipe design and baseline configuration.
• Support continuous improvement and applicable batch record changes.
• Follow up on BT tickets and resolve EBR issues.
• Adhere to procedures; identify deviations/exceptions and escalate as needed.
• Adhere to safety procedures and GMP/GDP practices.
• Reassess/participate in agile change environment to drive continuous improvement.
• Participate in cross-functional teams to support, enhance, and upgrade AMPS.
• Assist with controlling/tracking periodic EBR procedure updates and emergency changes.
• Attend scheduled training and provide cross-training across AMPs areas.

Skills

Pharmaceutical experience

Data management

Systems analyst

Quality Tracking Systems

EBR build

MES build

HTML

Java

Object-oriented programming

Quality Assurance

Education

Bachelor’s/Associate/High School Diploma in relevant field

Tools

M1 Certification

Yellow Belt

Pfizer Human Performance methodologies

HTML

Java

Job description

Scorpion Therapeutics seeks an experienced EBR/ MES specialist to design, revise, and support electronic batch records. You will drive change controls, assist end users, and coordinate with cross-functional teams to ensure accurate parameter capture and compliant documentation.

Responsibilities include process mapping, protocol verification, and continuous improvement of batch record workflows within a GMP/GDP environment. Collaboration with SMEs and operators is essential for success.