Engineer/Scientist-Technical Operations Validation

About the role

This position requires knowledge of cGMPs, excellent technical writing, and problem-solving skills. It is part of the Contamination Control team and involves managing validation activities, coordinating with functional groups, and ensuring compliance with internal and external requirements.

Key Objectives and Deliverables

• Develop and execute qualification and validation documents, including protocols and reports, product stage determination documents, and cleaning execution plans.
• Review protocols and technical reports within and external to Technical Operations.
• Perform cleaning validation/verification sampling, small-scale studies, and submit samples for analysis.
• Conduct hold studies to support qualified manufacturing hold time for process buffers.
• Schedule and coordinate cleaning and changeover activities with Manufacturing areas.
• Maintain the validated state of process equipment through cleaning monitoring and trending of cleaning cycles.
• Participate in design reviews to ensure design meets user requirements.
• Develop and/or update validation SOPs and policies; prioritize validation activities.
• Communicate and document status to management and appropriate departments.
• Use effective project management skills to manage multiple activities and ensure on-time project delivery.
• Provide technical evaluations of complex validation issues supporting discrepancy/deviation investigations and develop corrective action plans as required.
• Evaluate changes to the validated state of systems through change control procedures and participate in planning and implementation of changes.
• Represent the department as a subject matter expert (SME) during regulatory inspections.
• Participate in Process Flow Teams as needed.

Basic Requirements

• Position is banded; education and years of experience in a cGMP biopharmaceutical or pharmaceutical manufacturing and/or development environment will be considered for initial placement within the band.
• Ability to work with others in a fast-paced environment.
• Strong communication skills, both oral and written, to effectively communicate technical information in a clear and concise manner within a GMP environment.
• Strong analytical, problem-solving, and excellent interpersonal skills.
• Proficient in MS Office (Word, Excel, Project, Outlook, etc.).
• Understanding of key Data Integrity principles (ALCOA+) to ensure requirements are aligned to appropriate testing strategies.

Preferred Qualifications

• Knowledge of validation lifecycle approach and FDA/international regulatory requirements.
• Knowledge of contamination control strategies.
• Experience with the following applications/systems is a plus: TrackWise, KNEAT, LIMS.

Education Requirements

• Bachelor’s degree in engineering, science, or related discipline.

Other Information

• Travel not required.
• Lifting required (no more than 50 lbs.).
• Occasional off-hours work to accommodate manufacturing schedule.
• On a non-routine basis, confined space entry and tank entry with the use of a harness may be required.

Pay

The anticipated compensation for this role is $72,000 – $116,000. Candidates will be placed within the range based on experience, skills, internal equity, and market considerations.

Benefits

• Comprehensive benefits package including paid time off (holidays, vacation, and additional leave).
• Medical, dental, and vision insurance.
• Life insurance.
• Company-matched retirement savings plan.
• Wellness programs.
• Short- and long-term disability benefits.

Schedule

This role requires up to 10% travel, on-call availability, and may involve shift work. Hybrid work flexibility may be available based on business needs.