Pharma Process SME & Lean Six Sigma Champion

Scorpion Therapeutics

Petersburg (VA)

On-site

USD 120,000 - 160,000

Full time

7 days ago
Be an early applicant

Get more replies from employers

Send a job-specific resume in minutes.

Benefits offered by this job

Annual bonus
Generous PTO
Health, dental, vision

Job summary

Scorpion Therapeutics in Petersburg, VA seeks a Site Subject Matter Expert to provide process, technical, and strategic support for the department, lead projects, and coach Process Professionals.

You will communicate with vendors, oversee deviations and validations, drive Lean/Six Sigma improvements, and present status to Senior Management while ensuring safety and regulatory compliance.

Qualifications

  • Bachelor’s degree in engineering/tech with 8+ years manufacturing experience (pharma preferred).
  • LEAN experience/training.
  • Strong written, investigative, and computer skills.
  • Knowledge of change control and QMS; validation knowledge (product/tech transfer preferred).
  • Regulatory audit/inspection experience.
  • Knowledge of electronic manufacturing systems/master data (e.g., SAP, PAS-X).
  • Adult learning/ability to train and coach.

Responsibilities

  • Provide process, technical, and strategic support as the Site Subject Matter Expert (SME) for the department.
  • Lead and support various projects based on evolving business needs.
  • Coach/mentor Process Professionals.
  • Communicate with vendors and engineering firms regarding projects and technical issues.
  • Complete assigned projects/tasks within cost, quality, and schedule requirements.
  • Present project status updates to Senior Management.
  • Support senior leadership in strategic discussions and decision making.
  • Own area content and process knowledge; perform periodic reviews, validation processes, and reporting.
  • Drive continuous improvement, productivity, and cost reduction through technical expertise.
  • Provide technical oversight for deviations, root cause analysis, validation, and process changes/improvements.
  • Evaluate process/maintenance data; guide continuous improvements using Lean and Six Sigma.
  • Serve as technical expert to auditors/inspectors.
  • Share best practices across departments and NN sites; support other areas with process knowledge.
  • Identify and implement process needs and improvement opportunities; support achievement of department goals.
  • Lead guidance for complex maintenance matters.
  • Communicate production/industry trends to drive cGMP.
  • Implement new process/maintenance technologies and coordinate changes per regulatory procedures.
  • Follow all safety and environmental requirements.

Skills

LEAN
Six Sigma
Problem solving
Change control
QMS
Audit/inspection readiness
SAP
PAS-X
Training & coaching
SOP reading

Education

Bachelor’s degree (engineering/technology/related)
Associate’s degree
High School/GED

Tools

SAP
PAS-X

Job description

Scorpion Therapeutics in Petersburg, VA seeks a Site Subject Matter Expert to provide process, technical, and strategic support for the department, lead projects, and coach Process Professionals.

You will communicate with vendors, oversee deviations and validations, drive Lean/Six Sigma improvements, and present status to Senior Management while ensuring safety and regulatory compliance.

Get your free, confidential resume review.
or drag and drop your file here.
Similar jobs

Similar jobs worth comparing

Lead Process Specialist: Lean, Validation & Tech Transfer
Lead Process Specialist: Lean, Validation & Tech Transfer

Novo Nordisk A/S • Petersburg (VA)

On-site
USD 120,000 - 170,000
Leading pay and annual bonus
14 paid holidays
Health, Dental, Vision insurance – day
+5
Packaging Operations Engineer - Lean Six Sigma Leader
Packaging Operations Engineer - Lean Six Sigma Leader

Scorpion Therapeutics • Holland (MI)

On-site
USD 90,000 - 120,000
Competitive compensation
Career development
Family benefits
Senior Process Engineer - GMP Validation & Optimization
Senior Process Engineer - GMP Validation & Optimization

Scorpion Therapeutics • New Jersey

On-site
USD 95,000 - 140,000
Paid time off
Medical/dental/vision insurance
401(k) plan
Senior Process Validation & Controls Engineer (Drug Substance)
Senior Process Validation & Controls Engineer (Drug Substance)

Scorpion Therapeutics • Town of East Greenbush (NY)

On-site
USD 90,000 - 130,000
Quality Systems Leader - QMS & Compliance
Quality Systems Leader - QMS & Compliance

Scorpion Therapeutics • Thousand Oaks (CA)

On-site
USD 90,000 - 130,000
Senior Scientist I: Small-Molecule Process Development
Senior Scientist I: Small-Molecule Process Development

Scorpion Therapeutics • United States

On-site
USD 150,000 - 210,000
Senior Transformation Leader, Lean & Six Sigma
Senior Transformation Leader, Lean & Six Sigma

RXinsider LTD. • Jersey Shore, Northern (KY)

Hybrid
USD 120,000 - 170,000
Lean Initiatives Project Lead
Lean Initiatives Project Lead

Scorpion Therapeutics • Town of Vermont (WI)

On-site
USD 90,000 - 120,000
Manufacturing Operations Coach - Process Excellence
Manufacturing Operations Coach - Process Excellence

Scorpion Therapeutics • Clayton (NC)

On-site
USD 70,000 - 95,000
Performance bonus
Health/dental/vision benefits
8% 401(k) contribution + match
+5
Site Process SME & Improvement Lead
Site Process SME & Improvement Lead

Biopharma Careers • Petersburg (VA)

On-site
USD 120,000 - 160,000
Health Insurance
Dental Insurance
Vision Insurance
+7