Senior Quality Assurance Engineer - cGMP

CT19; Wisconsin; On-site; USD 110,000 - 150,000; Full time

Job summary

CT19 is seeking a Senior Quality Assurance Engineer to lead commissioning, qualification, and validation for a first-of-a-kind nuclear medicine production facility. You will own Master Validation Plan activities, oversee C&Q across equipment, utilities and processes, and drive validation reports in a highly regulated environment.

Ideal candidates have 5+ years in QA/validation within cgmp pharma manufacturing, deep knowledge of 21 CFR and cGMP, and experience with C&Q programs.

Qualifications

• 5+ years of Quality Assurance or Validation experience within a cGMP pharmaceutical/manufacturing environment.
• Strong knowledge of 21 CFR and cGMP requirements.
• Experience establishing and executing C&Q / validation programmes.
• Understanding of regulated laboratory methods and instrumentation.
• Radiopharmaceutical experience would be highly desirable.

Responsibilities

• Establishing and executing the Master Validation Plan.
• Equipment, utility and facility C&Q activities.
• Developing Process Validation and Cleaning Validation programmes.
• Supporting QC laboratory method validation.
• Developing SOPs for qualification, requalification and revalidation.
• Leading FMEA/PFMEA and risk assessment activities.
• Software and process-control validation.
• Stability testing plans and protocols.
• Supplier audits and Approved Supplier List development.
• Reviewing validation data and producing final qualification/validation reports.
• Working with Engineering, Production, Chemistry, QC and external stakeholders.

Skills

Quality Assurance

Validation

cGMP

21 CFR

FMEA/PFMEA

Education

Bachelor's degree in Engineering, Radiochemistry, Life Sciences

Job description

Help bring an advanced nuclear medicine production facility into cGMP operation.

We are supporting an innovative nuclear technology company developing a first-of-a-kind medical isotope production facility, designed to manufacture critical radioisotopes used in diagnostic imaging and cancer treatment.

They are looking for a Senior Quality Assurance Engineer to take a key role in the commissioning, qualification and validation of the facility, its equipment, utilities and cGMP manufacturing processes.

This is an opportunity to join a highly technical programme as it moves toward commercial production, with significant ownership over how its quality and validation systems are established.

The Role

You will be responsible for areas including:

• Establishing and executing the Master Validation Plan
• Equipment, utility and facility Commissioning & Qualification (C&Q)
• Developing Process Validation and Cleaning Validation programmes
• Supporting QC laboratory method validation
• Developing SOPs for qualification, requalification and revalidation
• Leading FMEA/PFMEA and risk assessment activities
• Software and process-control validation
• Stability testing plans and protocols
• Supplier audits and Approved Supplier List development
• Reviewing validation data and producing final qualification/validation reports
• Working closely with Engineering, Production, Chemistry, QC and external stakeholders

What We're Looking For

• 5+ years of Quality Assurance or Validation experience within a cGMP pharmaceutical/manufacturing environment
• Strong knowledge of 21 CFR and cGMP requirements
• Experience establishing and executing C&Q / validation programmes
• Understanding of regulated laboratory methods and instrumentation
• Bachelor's degree in Engineering, Radiochemistry, Life Sciences or a related discipline
• Radiopharmaceutical experience would be highly desirable
• Comfortable operating in a technically complex, highly regulated environment

Why Join?

This isn't maintaining an established QA programme. You'll have the opportunity to help build and qualify a first-of-a-kind facility, working at the intersection of nuclear technology, radiopharmaceutical manufacturing and cancer medicine.

If you have strong cGMP validation experience and want to work on something considerably more interesting than a conventional pharmaceutical manufacturing facility, I'd be keen to speak.