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Quality Engineer - Utility and Facility Validation


Experience:
Minimum of three (3) years' relevant experience performing utility and facility qualification/validation activities within a pharmaceutical, diagnostic, biotechnical, or chemical processing environment. Experience within an aseptic manufacturing and processing plant is preferred.

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.

Position Summary
This role designed to respond to the growth of the Company and its need to add additional capabilities in the generic injectable sterile and nasal product marketplace. This position is responsible for validation of all clinical and commercial generic and new R&D drug development activities in support of the pipeline of products.

General Purpose of Job:
This position is responsible for generating and executing designs of experiments, feasibility studies, qualification studies and validation studies as well as generating final reports for the qualification of utility systems and new / modified facilities. The individual will be a Subject Matter Expert (SME) expected to oversee the overall validation/qualification program as it pertains to the utility systems (i.e. USP Purified Water, USP Water-for-Injection, Clean Compressed Air, Pure / Clean Steam, etc.) and new / modified facilities. Activities require coordination of staffing from the supporting departments, scheduling / planning execution activities, ensuring samples are provided to the various test laboratories, and staffing protocol execution activities in conjunction with Operations and Quality; as well as the review and tabulation of results, and report generation.

This position will also interact frequently with regulatory/compliance personnel at DPT Laboratories, in San Antonio, TX and Renaissance Pharma. He/She will assure compliance to all FDA and international regulations for equipment and process qualifications.

The role will report directly to the Manager of Quality Engineering in the Lakewood, NJ site 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:
Responsible for the qualification / validation studies required to support new / modified or seasonal qualification / validation of cGMP utility systems and facilities.
Generate list of prerequisites required prior to initiating commissioning, feasibility, qualification or validation activities.
Generate protocols, technical memos, feasibility / development studies, sampling plans, acceptance criteria, and final reports.
Coordinate activities across multiple departments to support, manpower, sampling, laboratory testing, and tabulation / evaluation of results.
Communicate status of prerequisites, open items, deviations, execution activities and project timelines.
Collect and tabulate laboratory data, review laboratory data for errors and discrepancies, and transcribe results into final reports.
Generate, review and approve qualification / validation procedures.
Generate final reports, compile historical data packages, and route documents for approval.
Generate and maintain a site qualification / validation procedures in order as they apply to the scope of the job.
Review and approve interventions and assess product impact / potential product risk as the result of atypical interventions.
Review and assess Change Controls and Deviations associated with or impacting the utility systems or the facility.


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