Process Specialist - Virginia

Scorpion Therapeutics; Petersburg (VA); On-site; USD 120,000 - 160,000; Full time

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

The Position

• 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.

Essential Functions

• 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.

Minimum Qualifications

• Bachelor’s degree (engineering/technology/related) + 8+ years manufacturing experience (preferably pharma).
• OR Associate’s + 10+ years; OR High School/GED + 12+ years.
• Thorough systematic problem-solving; LEAN experience/training.
• Strong written, investigative, and computer skills.
• Ability to read/understand complex product documentation and SOPs.
• Continuous improvement via Lean/Six Sigma; proven planning/organizing and execution.
• 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.

Benefits

• Leading pay and annual performance bonus; generous PTO incl. 14 paid holidays.
• Health, dental, vision insurance (effective day one); 8% 401(k) contribution + company match option.
• 14 weeks paid parental leave; 6 weeks paid family medical leave.
• Free access to Novo Nordisk–marketed pharmaceutical products; tuition assistance; life & disability insurance; employee referral awards.