Experience: Minimum of three (3) years’ relevant experience performing validation activities within an aseptic pharmaceutical environment.
Education: Bachelor’s degree or higher in Engineering, Life Sciences or related discipline (Engineering, Chemical Engineering, Chemistry, Biology, etc.)
Familiarity with current industry practices and guidelines including those required / outlined by the FDA, ISO, EU and ICH.
Quality Engineer - Process Validation
GENERAL PURPOSE OF JOB
This position is responsible for supporting the planning, protocol development, developing sampling plans, supporting the execution of and generating final reports for all types of process validation activities. The individual will be a Subject Matter Expert (SME) expected to oversee the overall validation/qualification program for new process as well as continued process monitoring / re-qualification including scheduling and supporting the staffing of protocol execution activities in conjunction with Operations and Quality, coordinating testing with internal and external test laboratories, review and tabulation of results, and report generation.
The role will report directly to the Supervisor of Quality Engineering in the for day-to-day direction and guidance. This role will require a person with a desire and passion to excel within the Company and who can work independently in a highly matrixed, collaborative environment.
ESSENTIAL DUTIES AND RESPONSIBILITIES
1. Responsible for the qualification / validation studies required to support the introduction of new manufacturing, filling and packaging processes as well as the monitoring / re-qualification of existing processes and challenging integrated lines.
2. Generate list of prerequisites required prior to initiating process qualification / validation activities.
3. Generate protocols, technical memos, feasibility / development studies, sampling plans, acceptance criteria, and final reports.
4. Support the generation of defect inspection criteria and AQL based sampling plans.
5. Develop qualification / validation rationales for requirement of number of challenge runs, bracketing, matrix, and critical process / product parameters.
6. Communicate status of prerequisites, open items, deviations, execution activities and project timelines.
7. Collect and tabulate laboratory data, review laboratory data for errors and discrepancies, and transcribe results into final reports.
8. Generate, review and approve validation procedures.
9. Generate final reports, compile historical data packages, preform statistical evaluation, generate discussion of results and scientific based conclusions, and route documents for approval.
10. Generate and maintain a site process qualification / validation program plan.
11. Review and approve interventions and assess product impact / potential product risk as the result of atypical interventions.