Senior Process Engineer III - Scale-Up & Tech Transfer

STAQ Pharma; Denver (CO); Presencial; USD 120.000 - 180.000; Jornada completa

Descripción de la vacante

STAQ Pharma in Denver, CO seeks a Process Engineer III to serve as a senior technical resource within Manufacturing Science & Technology, leading high-impact projects in process development, technology transfer, equipment qualification, and validation strategies.

The role provides technical ownership, mentoring, and cross-functional leadership to ensure robust, compliant, scalable processes aligned with business goals.

Formación

• Bachelor’s degree in engineering or related technical field required.
• Minimum of 6 years of experience in process development, process engineering, or related role within a cGMP environment.
• Experience leading complex process improvement, validation, technology transfer, or manufacturing support projects.
• Experience providing technical leadership and mentoring to cross-functional teams.

Responsabilidades

• Serve as technical owner or SME for manufacturing processes, technologies, equipment, and implementation strategies.
• Lead complex process development, optimization, scale-up, technology transfer, and equipment implementation initiatives.
• Define and drive technical strategy for process improvements, controls, risk mitigation, validation readiness, and long-term robustness.
• Lead complex troubleshooting, investigations, root cause analysis, CAPA, and continuous improvement with cross-functional teams.
• Author, review, or approve protocols, reports, risk assessments, batch records, SOPs, and other controlled documents.
• Lead equipment qualification and process validation strategy, including protocol design, data review, deviation resolution, and report support.
• Evaluate process performance using data trending, statistics, and process capability to improve safety, quality, delivery, and cost.
• Manage vendor and equipment interactions, design reviews, testing strategy, implementation planning, and lifecycle support.
• Lead cross-functional project teams with scope, schedule, budget, risk, documentation, and stakeholder communication.
• Mentor Process Engineer I/II and provide technical leadership to Manufacturing, Quality, Engineering, and other departments.
• Support audits, regulatory responses, and quality system activities as a technical resource when required.
• Maintain expertise in applicable regulatory requirements, industry guidance, and emerging technologies.

Conocimientos

cGMP knowledge

Data analysis

Technical writing

Cross-functional leadership

Sterile manufacturing

Validation strategies

Process control

Six Sigma

DOE

FMEA

Lifecycle management

Educación

Bachelor’s degree in engineering

Descripción del empleo

STAQ Pharma in Denver, CO seeks a Process Engineer III to serve as a senior technical resource within Manufacturing Science & Technology, leading high-impact projects in process development, technology transfer, equipment qualification, and validation strategies.

The role provides technical ownership, mentoring, and cross-functional leadership to ensure robust, compliant, scalable processes aligned with business goals.