OneTrust

Senior Manager, Execution Automation Systems

OneTrust

full-time

Posted on:

Location Type: Hybrid

Location: Titusville • New Jersey • Pennsylvania • United States

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Salary

💰 $122,000 - $208,250 per year

Job Level

Senior

About the role

  • Represent Engineering in Facility & Systems Design, Qualification and Startup, through transfer to the end user.
  • Support tech transfer activities through process validation and regulatory approval.
  • Author, approve or support the writing of URSs (User Requirement Specifications), Change Controls, Impact Assessments, technical evaluations, design specifications and operational documents.
  • Provide technical support to Engineering/MAM, Design, Automation, IT, Construction Management, CQV/Start-up, Operations, and EHS teams as required during the project phase.
  • Participate and have ownership of decisions made in safety reviews (EHS by Design, HAZOPs, machine safety, ergonomics, etc.).

Requirements

  • Minimum 8 years of Manufacturing OT and Automation work experience in a Manufacturing Operations and/or Engineering environment.
  • Experience within Pharmaceuticals, Biopharmaceuticals / Large Molecule, or equivalent industry.
  • Experience working with Emerson DeltaV process and batch control systems.
  • Thorough knowledge of ISA S88/S95 standards.
  • Experience with PLC-controlled equipment, process automation hardware and software, robotics, OT networks infrastructure and systems.
  • Commissioning/qualification/validation experience.
  • Experience with Cell Therapy (CAR-T) is an asset.
  • Bachelor’s degree is required; advanced degree or focused degree preferred in Engineering, Bioscience Engineering, Industrial Engineering, Pharmacy, Biochemistry or related field.
Benefits
  • Health insurance
  • 401(k) matching
  • Flexible work hours
  • Paid time off
  • Remote work options
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Manufacturing OTAutomationProcess validationRegulatory approvalUser Requirement Specifications (URS)Change ControlsImpact AssessmentsCommissioningQualificationValidation
Soft Skills
Technical supportDecision makingSafety reviewsOwnership