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5792 - EBR MES Project Engineer / Project Engineer

Kalamazoo, MI

Description

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

  • We empower and support our colleagues
  • We commit to client success at every turn
  • We have the courage to do the right thing
  • We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
  • We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Job Summary: The EBR MES Project Engineer will lead critical project execution activities focused on Electronic Batch Record (EBR) system implementation, integration, and lifecycle management for aseptic fill pharmaceutical manufacturing. This role works at the intersection of operations, equipment owners, engineering, and quality teams to ensure alignment and execution of compliant, efficient, and effective manufacturing workflows. The Project Engineer supports capital and operational projects involving process equipment, automation interfaces, and digital manufacturing systems, including MES/EBR platforms, with a strong emphasis on data integrity, GMP compliance, and cross-functional coordination.

This role will ensure that EBR development and implementation supports right-first-time batch execution, robust exception handling, and seamless integration with filling equipment and quality workflows. Project Engineers will manage internal and external Verista and client stakeholders to deliver project outcomes that meet timelines, budget, and regulatory expectations, while optimizing manufacturing efficiency.

Key Responsibilities:

  • Lead planning, development, and deployment of Electronic Batch Records (EBR) for aseptic fill operations in alignment with cGMP requirements and client-specific workflows
  • Interface with Operations, Quality, Engineering, IT, and Equipment Owners to gather requirements, document process flows, and ensure complete alignment across functional areas
  • Partner with MES/EBR configuration and validation teams to support functional design specification (FDS) creation, risk assessments, and testing activities
  • Coordinate system integration efforts between equipment automation systems (PLC/SCADA) and MES/EBR platforms to ensure accurate data capture and real-time batch execution
  • Drive change control activities related to EBR implementation or modification, ensuring documentation is audit-ready and compliant with 21 CFR Part 11 and Annex 11 requirements
  • Maintain clear and detailed records of specifications, functional changes, and validation deliverables for regulatory inspection readiness
  • Lead cross-functional meetings and vendor coordination to ensure design alignment and readiness of EBR systems before go-live
  • Support exception handling configuration and deviation minimization strategies through proactive batch flow design and stakeholder feedback loops
  • Analyze and optimize batch execution timelines using EBR system reporting to drive continuous improvement initiatives

Requirements:

  • Bachelor’s Degree in an industry-related field or equivalent required
  • 2+ years of job-related experience required
  • Proven experience with Electronic Batch Record (EBR) systems (e.g., Werum PAS-X, POMSnet, Syncade, AMPs etc.) in GMP pharmaceutical manufacturing, preferably aseptic fill/finish operations
  • Demonstrated ability to lead cross-functional teams through design, implementation, and validation of MES/EBR solutions
  • Strong understanding of cGMPs, data integrity principles, and regulatory compliance (21 CFR Part 11, EU Annex 11)
  • Experience leading risk assessments, URS/FDS generation, and validation documentation efforts
  • Ability to mentor team members and guide junior engineers through complex digital manufacturing project phases
  • Advanced project management skills, including use of Microsoft Project and/or other tracking tools
  • Excellent interpersonal and communication skills to align stakeholders at all organizational levels
  • Experience with change control processes, deviation handling, and system lifecycle management
  • Familiarity with equipment integration into EBR/MES environments (e.g., isolators, fillers, VHP systems, CIP/SIP systems)

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

*Verista is an equal opportunity employer.

National (US) Range

$70,491 - $113,521 USD

Benefits

Why Choose Verista?

  • High growth potential and fast-paced organization with a people-focused culture
  • Competitive pay plus performance-based incentive programs
  • Company-paid Life, Short-Term, and Long-Term Disability Insurance.
  • Medical, Dental & Vision insurances
  • FSA, DCARE, Commuter Benefits
  • Supplemental Life, Hospital, Critical Illness and Legal Insurance
  • Health Savings Account
  • 401(k) Retirement Plan (Employer Matching benefit)
  • Paid Time Off (Rollover Option) and Holidays
  • As Needed Sick Time
  • Tuition Reimbursement
  • Team Social Activities (We have fun!)
  • Employee Recognition
  • Employee Referral Program
  • Paid Parental Leave and Bereavement

Verista collects and processes personal data in accordance with applicable data protection laws.  If you are a California Job Applicant, see the privacy notice for further details. 

For more information about our company, please visit us at Verista.com

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