Process Engineer II

Alexander Technology Group; North Billerica (MA); On-site; USD 55,000 - 69,000; Full time

Job summary

Alexander Technology Group is seeking an experienced Process Engineer to support radiopharmaceutical manufacturing, including product and process support, engineering, and regulatory compliance. The role requires hands-on cGMP experience in sterile production and medical devices, with a strong emphasis on problem solving and quality systems.

Responsibilities include leading deviations investigations, CAPA implementation, and drafting technical documents, with collaboration across QA, operations,

Qualifications

• Bachelor's degree in Chemical Engineering, Mechanical Engineering, Nuclear Engineering, Chemistry, or a related technical field.
• 6+ years of experience in medical device manufacturing, with a focus on sterile injectable or radiopharmaceutical production.
• Strong understanding of cGMPs, aseptic processing, cleanroom operations, and medical device/combination product regulations (21 CFR 210, 21 CFR 211, 21 CFR 820, ISO 13485).
• Demonstrated ability to investigate deviations, problem solve, and execute changes within a quality system framework. Advanced technical writing skills required.
• Hands-on experience with equipment commonly used in sterile fill/finish operations.
• Demonstrated ability to lead process validation, equipment qualification, and risk management efforts.

Responsibilities

• Provide day-to-day technical support to manufacturing operations, ensuring reliable production.
• Lead investigations for moderate- to high-complexity deviations, perform root cause analyses, and implement CAPAs in collaboration with QA and operations teams.
• Author and revise controlled documents, including manufacturing documentation, technical reports, protocols, and risk assessments.
• Support process monitoring, trending, and data analysis activities to drive continuous improvement and maintain a state of control.
• Participate in cross-functional teams for process changes, equipment upgrades, and lifecycle projects, ensuring regulatory and quality compliance.
• Act as a technical contributor in change control execution, including impact assessments and protocol generation.
• Support and/or lead multiple technical transfers, scale-ups, and process validation activities.
• Collaborate with stakeholders in Manufacturing, QA, QC, Engineering, and Supply Chain for timely and compliant execution of campaigns.
• Ensure compliance with regulations including 21 CFR Parts 210, 211, 820, EU GMP Annex 1, and radiation safety requirements.
• Support readiness activities for internal and regulatory audits, including documentation review and SME participation.

Skills

Interpersonal skills

Communication skills

Technical writing

Excel

Data analysis

Education

Bachelor's degree in Chemical Engineering, Mechanical Engineering, Nuclear Engineering, Chemistry, or related technical field

Advanced degree preferred

Tools

TrackWise

CATSWeb

Job description

Position Summary

Client is seeking an experienced and driven Process Engineer to support key functions for radiopharmaceutical manufacturing which includes product support, process support, process engineering, equipment/utility engineering, maintenance programs, and technical troubleshooting in support of automated manufacturing lines. The individual brings hands-on experience in cGMP manufacturing support, with a strong understanding of sterile drug production, radiopharmaceutical workflows, and medical device quality systems.

Key Responsibilities

• Provide day-to-day technical support to manufacturing operations, ensuring reliable production.
• Lead investigations for moderate- to high-complexity deviations, perform root cause analyses, and implement CAPAs in collaboration with QA and operations teams.
• Author and revise controlled documents, including manufacturing documentation, technical reports, protocols (e.g., process validation, equipment qualification), and risk assessments.
• Support process monitoring, trending, and data analysis activities to drive continuous improvement and maintain a state of control.
• Participate in cross-functional teams for process changes, equipment upgrades, and lifecycle projects, ensuring alignment with regulatory and quality requirements.
• Act as a technical contributor in change control execution, including impact assessments, protocol generation, and implementation planning.
• Support and/or lead multiple technical transfers, scale-ups, and process validation activities.
• Collaborate with stakeholders in Manufacturing, QA, QC, Engineering, and Supply Chain to ensure timely and compliant execution of manufacturing campaigns.
• Ensure compliance with applicable regulations, including 21 CFR Parts 210, 211, 820, EU GMP Annex 1, and radiation safety requirements.
• Support readiness activities for internal and regulatory audits, including documentation review and SME participation.

Qualifications

• Bachelor's degree in Chemical Engineering, Mechanical Engineering, Nuclear Engineering, Chemistry, or a related technical field (advanced degree preferred).
• 6+ years of experience in medical device manufacturing, with a strong focus on sterile injectable or radiopharmaceutical production. is a plus.
• Solid understanding of cGMPs, aseptic processing, cleanroom operations, and medical device/combination product regulations (21 CFR 210, 21 CFR 211, 21 CFR 820, ISO 13485).
• Demonstrated ability to investigate deviations, problem solve, and execute changes within a quality system framework. Advanced technical writing skills required.
• Hands-on experience with equipment commonly used in sterile fill/finish operations.
• Demonstrated ability to lead process validation, equipment qualification, and risk management effor
• Self-starter with strong interpersonal and communication skills; able to work independently and in cross-functional teams.
• Proficiency in Excel, data analysis tools, and electronic document/change control systems (e.g., TrackWise, CATSWeb). Skilled at presenting technical content to technical and non-technical audiences.

Preferred Experience

• Expereince with lean manufacturing principles and driving process improvements in any scale.
• Experience in lifecycle management of commercially approved pharmaceutical products and devices.
• Experience in managing large cross-functional projects in a matrix environment.

Pay range $40-$50/hr

ATG456