Process Engineer III

STAQ Pharma Inc; Denver (CO); On-site; USD 85,000 - 119,000; Full time

Job summary

STAQ Pharma Inc in Denver, CO is seeking a Process Engineer III to lead complex, high-impact projects within Manufacturing Science & Technology. You will own processes, drive technology transfer, and mentor teams to ensure robust, scalable manufacturing.

The role focuses on process development, scale-up, equipment qualification, validation strategy, and regulatory readiness, with cross-functional collaboration to meet business objectives.

Qualifications

• Bachelor’s degree or higher in engineering or related technical field.
• Minimum of 6 years of experience in process development, process engineering, manufacturing engineering, MSAT, or a related role within a cGMP environment. Experience in aseptic processing preferred.
• Demonstrated experience leading complex process improvement, process validation, equipment qualification, technology transfer, or manufacturing support projects.
• Experience providing technical leadership, mentoring engineers, and influencing cross-functional teams without direct authority.

Responsibilities

• Serve as a technical owner or subject matter expert for assigned manufacturing processes, process technologies, equipment, and implementation strategies.
• Lead complex process development, optimization, scale-up, technology transfer, new product introduction, and equipment implementation initiatives.
• Define and drive technical strategy for process improvements, process controls, risk mitigation, validation readiness, and long-term manufacturing robustness.
• Lead complex troubleshooting, investigations, root cause analysis, countermeasure implementation, CAPA, and continuous improvement activities involving cross-functional teams.
• Author, review, or approve complex protocols, reports, technical justifications, risk assessments, batch record content, SOPs, work instructions, and other controlled documents.
• Lead equipment qualification and process validation strategy for assigned projects, including protocol design, execution oversight, data review, deviation resolution, and report approval support.
• Evaluate process performance using data trending, statistical analysis, process capability, and risk-based tools; recommend and implement actions to improve safety, quality, delivery, and cost performance.
• Leadvendor and equipment interactions, including user requirements, technical evaluations, design reviews, testing strategy, implementation planning, and lifecycle support.
• Lead cross-functional project teams and manage complex project scope, schedule, budget, technical risk, documentation, and stakeholder communication.
• Mentor Process Engineer I/II personnel and provide technical leadership to Manufacturing, Quality, Engineering, and other departments.
• Support audits, inspections, customer requests, regulatory responses, and quality system activities as a technical resource whenrequired.
• Maintainexpertisein applicable regulatory requirements, industry guidance, and emerging technologies relevant to assigned processes.
• Perform other duties as assigned to meet business needs.

Skills

Process leadership

MSAT

Data analysis

cGMP knowledge

Aseptic processing

Cross-functional leadership

Education

Bachelor’s degree in engineering or related field

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Process Engineer III

Professional Denver, CO, US

12 days ago Requisition ID: 1337

Salary Range: $85,000.00 To $119,000.00 Annually

Job Summary:

The Process Engineer III serves as a senior technical resource within Manufacturing Science & Technology and leads complex, high-impact projects related to process development, process improvement, technology transfer, equipment qualification, validation strategy, and manufacturing support. This role provides technical ownership, mentoring, and cross-functional leadership to ensure processes are robust, compliant, scalable, and aligned with business objectives.

• Serve as a technical owner or subject matter expert for assigned manufacturing processes, process technologies, equipment, and implementation strategies.
• Lead complex process development, optimization, scale-up, technology transfer, new product introduction, and equipment implementation initiatives.
• Define and drive technical strategy for process improvements, process controls, risk mitigation, validation readiness, and long-term manufacturing robustness.
• Lead complex troubleshooting, investigations, root cause analysis, countermeasure implementation, CAPA, and continuous improvement activities involving cross-functional teams.
• Author, review, or approve complex protocols, reports, technical justifications, risk assessments, batch record content, SOPs, work instructions, and other controlled documents.
• Lead equipment qualification and process validation strategy for assigned projects, including protocol design, execution oversight, data review, deviation resolution, and report approval support.
• Evaluate process performance using data trending, statistical analysis, process capability, and risk-based tools; recommend and implement actions to improve safety, quality, delivery, and cost performance.
• Leadvendor and equipment interactions, including user requirements, technical evaluations, design reviews, testing strategy, implementation planning, and lifecycle support.
• Lead cross-functional project teams and manage complex project scope, schedule, budget, technical risk, documentation, and stakeholder communication.
• Mentor Process Engineer I/II personnel and provide technical leadership to Manufacturing, Quality, Engineering, and other departments.
• Support audits, inspections, customer requests, regulatory responses, and quality system activities as a technical resource whenrequired.
• Maintainexpertisein applicable regulatory requirements, industry guidance, and emerging technologies relevant to assigned processes.
• Perform other duties as assigned to meet business needs.

Qualification & Education Requirements:

• Bachelor’sdegreeorhigherin engineering or related technical fieldrequired.
• Minimum of 6 years of experience in process development, process engineering, manufacturing engineering, MSAT, or a related role within a cGMP environment. Experience in aseptic processingpreferred.
• Demonstrated experience leading complex process improvement, process validation, equipment qualification, technology transfer, or manufacturing support projects.
• Experience providing technical leadership, mentoring engineers, and influencing cross-functional teams without direct authority.

Required Skills:

• Advanced mechanical aptitude, technical judgment, and ability to resolve complex manufacturing and process issues.
• Strong understanding of cGMP requirements, quality systems, risk management, equipment qualification, process validation, and lifecycle process control.
• Demonstrated ability to lead complex cross-functional projects from concept through implementation and sustained operation.
• Strong data analysis skills, including statistical methods, process capability, process control, and trend evaluation.
• Excellent technical writing, communication, and presentation skills for technical, quality, operational, and leadership audiences.
• Ability to prioritize competing business needs, communicate risks, and make sound technical recommendations under tight deadlines.
• Experience in sterile, aseptic, pharmaceutical, biotechnology, or medical device manufacturing environments.
• Experience developing validation strategies, process control strategies, technology transfer plans, and lifecycle management approaches.
• Experience with lean manufacturing, Six Sigma, design of experiments, process characterization, FMEA, and statistical process control.
• Demonstrated ability toestablishtechnical standards, improve engineering practices, and coach other engineers.
  This role will remain open for at least 40 days or until the role has been filled