Operational Technology (OT) Integration Engineer

Merck KGaA Darmstadt Germany-posted 3 months ago
$113,000 - $169,400/Yr
Rockville, MD
Chemical Manufacturing
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Contract Testing Services is seeking an experienced Operational Technology (OT) Engineer who can bridge technical and security implementations with GxP compliance in our regulated environment. This role combines strategic oversight with hands-on technical process engineering to ensure both security and GxP compliance across our laboratory and OT environment.

  • Design & implement secure and robust architectures for Laboratory/OT Systems in line with stakeholder requirements and company architecture guidelines
  • Liaise with vendors to evaluate systems for their ability to meet business operational and security needs
  • Perform troubleshooting and root-cause analysis to systemically resolve issues
  • Blueprint system designs for multi-site deployment and scaling
  • Foster an environment of collaboration and psychological safety to support colleagues in their development of technical knowledge
  • Develop and implement appropriate cybersecurity controls and strategies to meet Contract Testing Service's Cybersecurity, regulatory, and operational requirements
  • Serve as the security liaison between IT/security teams, Life Sciences Sector and laboratory business units
  • Translate complex security requirements into actionable procedures and technical processes for laboratory testing environments
  • Conduct risk assessments specific to GxP testing data, systems, and processes
  • Design and implement automated validation scripting for regulated systems, leveraging technical and CI/CD experience
  • Complement Cyber Security controls with GxP data integrity requirements to reduce operational overheads
  • Perform security and support quality audits
  • Apply Lean Six Sigma methodologies to day-to-day operations and processes to improve operational efficiency
  • Analyse existing workflows to identify process deficiencies and security gaps while maintaining laboratory testing availability and integrity
  • Develop automated security testing procedures compatible with validation requirements
  • Create and maintain SOPs and wiki knowledgebases to support best practice and knowledge transfer
  • Bachelor's degree in Computer Science, Cyber Security, Engineering, Life Sciences (Biology/Chemistry) or related discipline
  • At least 5 years in an Operational Technology or Cybersecurity role
  • At least 5 years experience as a Windows Administrator
  • At least 8 years in a regulated Life Sciences environment
  • Strong understanding of GxP requirements and how they intersect with security controls
  • Experience implementing security controls in laboratory or biosafety testing environments
  • Demonstrated ability to develop technical processes and procedures
  • Expert knowledge of Scientific or Lab Data Management Systems
  • Experience of physically working with different Lab Instruments
  • Experience working with Physical hardware in a server room environment
  • Knowledge of relevant regulatory frameworks with Cyber Security (ISA / IEC 2443), ISO 27000 Data Integrity, GAMP / 21 CFR 11, GLP & GDP (EU, FDA, MHRA), CSV/CSA etc.
  • Attained or working towards additional degree (different academic area) in Computer Science or Cyber Security, Engineering, or Life Sciences (Biology/Chemistry)
  • Attained or working towards professional certifications in cybersecurity e.g. (CISSP, CISM, HCISPP, ASQ)
  • At least 5 years experience with validation of computerized systems in GxP environments
  • Background in laboratory technologies and biosafety testing platforms
  • Lean Six Sigma Green or Black Belt certification
  • medical, vision, and dental insurance
  • life insurance
  • disability insurance
  • 401(k)-matching program
  • paid time off
  • paid holidays
  • short-term or long-term incentive compensation, including cash bonuses
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