POMS MES Engineer (4+ Yrs Exp., Contract, On-Site Role)
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Experience Required:
Posted on:
4 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Title
POMS MES Engineer (4 Years HandsOn Experience)
Location
Worcester Massachusetts
Contract placement with Top 10 global biopharma client
About Biostrategenix
Biostrategenix is a life sciences consulting and engineering firm focused on simplifying quality and manufacturing execution in highly regulated environments. We partner with pharmaceutical and biotech organizations to design and implement practical compliant and sustainable systems that support rightfirsttime manufacturing and faster batch release.
Our philosophy is grounded in clarity lean principles and data integrity. We design solutions that reduce complexity eliminate waste and align with global regulatory expectationssystems that work for manufacturing and quality teams not against them. From MES and electronic batch records to quality system transformation we help organizations move from reactive compliance to proactive operational excellence.
At Biostrategenix engineers are expected to be handson technically deep and accountable. We value people who understand how systems actually run in production and who want to build solutions that endure.
Position Summary
Biostrategenix is seeking a POMS MES Engineer with 4 years of direct handson experience configuring and developing POMS or POMSnet Aquila solutions in GMP manufacturing environments.
This role is for an engineer who has written recipes configured workflows and built EBRsnot someone who has only used or administered POMS. You will support the full lifecycle of MES implementations from requirements and design through testing commissioning and qualification working closely with clients quality teams and crossfunctional stakeholders.
Key Responsibilities
POMS MES Configuration & Development
- Design configure and program POMS MES solutions including:
- Master recipes control recipes and operations
- Electronic Batch Records (EBRs)
- Material equipment and process models
- Execution workflows and exception handling
- Apply S88 and S95 standards to recipe and system design.
- Configure POMS functionality to support GMP manufacturing processes ensuring usability traceability and compliance.
- Participate in solution design discussions and contribute to system architecture decisions.
MES Project Execution
- Support MES projects across all lifecycle phases:
- Requirements gathering and functional specifications
- Configuration and build
- Unit testing integration testing and UAT
- Commissioning qualification and golive support
- Execute tasks independently while collaborating closely with senior engineers project managers and client teams.
- Troubleshoot system issues perform root cause analysis and implement sustainable fixes.
Systems Integration & Data Integrity
- Configure and support interfaces between POMS and external systems including:
- ERP (e.g. SAP)
- DCS/SCADA (e.g. DeltaV)
- LIMS QMS CMMS
- Data historians (e.g. PI)
- Work with relational databases (SQL preferred) to support data validation reporting and troubleshooting.
- Ensure data integrity audit readiness and compliance across integrated systems.
Compliance & Documentation
- Ensure MES solutions meet cGMP 21 CFR Part 11 and data integrity requirements.
- Author and support lifecycle documentation including:
- Functional and configuration specifications
- Test scripts and test evidence
- Qualification deliverables (IQ/OQ/PQ support)
- Apply GAMP 5 principles throughout system design and implementation.
Requirements
Required Qualifications
Education
- Bachelor of Science in Engineering Computer Science or a related technical discipline.
Experience
- 4 years of direct handson POMS MES experience in pharmaceutical or biotech manufacturing.
- Demonstrated experience writing and configuring POMS recipes and EBRs.
- Experience supporting MES projects through implementation testing and commissioning.
- Strong working knowledge of:
- S88 / S95
- GAMP 5
- cGMP and 21 CFR Part 11
- Experience integrating MES with ERP DCS/SCADA LIMS historians or related systems.
- Familiarity with warehouse and inventory management in a GMP environment.
- Experience working with relational databases (SQL).
- Strong technical writing and communication skills.
- Proficiency with Microsoft Office tools.
Preferred Qualifications
- Experience with POMSnet Aquila (onpremise or cloud deployments).
- Exposure to cloud or hybrid MES architectures.
- Experience supporting commercial manufacturing operations.
- Ability to mentor junior engineers or act as a technical resource within a project team.
Work Environment & Physical Requirements
- Combination of office and onsite manufacturing environments.
- Frequent use of computers and technical documentation tools.
- Ability to work in industrial settings including standing walking and navigating production areas as required.
Benefits
Why Biostrategenix
- Work on meaningful life sciences projects with real operational impact
- Strong emphasis on technical depth and handson engineering
- Collaborative culture focused on clarity and execution
- Opportunity to grow as a trusted MES subjectmatter expert
Required Skills:
What We Are Looking For Strongly Preferred Experience with data integrity requirements (21 CFR Part 11 Annex 11 etc.) Experience with pharmacopeia requirements (e.g. USP JP EP etc.) Experience in QC cGMP laboratory environment (analytical or microbiology) knowledge of cGxP and regulatory requirements for clinical and commercial DP/DS Strong expertise in Quality Control including proficiency in analytical techniques and ensuring product quality Proven experience in Quality Assurance Proficiency in Quality Management and oversight of quality-related processes Excellent analytical organizational and communication skills Excellent attention to detail leadership skills and practical problem-solving abilities Ability to be flexible with changing priorities Preferred Experience in analytical method transfer within a cGMP environment Knowledge of aseptic DP process Experience with lean six sigma/continuous improvement methodologies Relevant certifications or training in quality management GMP or auditing are advantageous
Required Education:
BS/BA in science/related field and 5 years of experience in bio-pharmaceutical/pharmaceutical industry MS/MA in science/related field and 3 years of experience in bio-pharmaceutical/pharmaceutical industry
