Chemical Process Engineer

Chemical Process Engineer
Empresa:

Wilmington Pharmatech


Chemical Process Engineer

Detalles de la oferta

Job Description

Wilmington PharmaTech (WPT) is looking for a Process / Production Engineer with GMP experience in the pharmaceutical industry to work in the Newark, DE area. The nature of this position is supporting the manufacturing team that creates drug products by working closely with supervisors, GMP operators, maintenance technicians and QA colleagues. Ideal candidates should have a strong understanding of Good Manufacturing Practices and new product development projects, and pharmaceutical/ chemical manufacturing. The position is set in a fast:paced start:up environment and shall require the individual to work on a broad range of tasks.

EDUCATIONAL AND PRIOR EXPERIENCE REQUIREMENTS:

A chemical engineering degree with a minimum of 3 years of experience is desired within either the
pharmaceutical/food industry or a manufacturing environment. Must have demonstrated experience with quality /safety systems in a manufacturing environment as well as exposure to normal process manufacturing activities like teamwork, shiftwork, etc. Specific experience in a GMP or FDA regulated facility is required.

REQUIRED SKILLS:

Strong interpersonal ability within a small manufacturing organization and the ability to demonstrate team skills, flexibility and adaptability.

Knowledge of OSHA, FDA, cGMP practices.

Configure plant equipment, such as reactors, pumps and filters for process scale:up from laboratory development work and assist in preparation of batch records.

Understand and help to develop pre:production equipment readiness checklists.

Works closely with QA to ensure proper and documented cleaning of equipment before and after production campaigns and between batches as needed.

Participates in the initial set up and operation of the equipment in a GMP setting.

Able to define and carry:out equipment training programs.

Basic understanding of sensors for pressure, flow, level, temperature, weight and controls.

Strong initiative (able to direct ones work efforts without supervision).

Strong problem:solving/ troubleshooting skills and strong communication skills : verbal and listening

Possess decision:making and judgment ability with regard to safety to self and others

Knowledge of safety systems for: Lockout Tagout, Confined Space Entry, Fall Protection, Forklift Safety (as a pedestrian and as a driver).

Create, read and understand batch records, SOPs and related documents.

Comply with all cGMP requirements as directed by the Quality department and management.

Ability to maintain attention around high temperature liquids, low temperature liquids, and high pressure gases.

Pass a criminal background check and drug screening test.

PHYSICAL REQUIREMENTS:

Safely moving product and raw material drums Ability to work at heights and in confined space.

Must be able to stand for long periods and must be able to lift up to 50 pounds.

Must be able to pass a respirator fit test.

Must be able to work outside of normal business hours when required by production demands for shift technical coverage, troubleshooting or other operating needs.

Must be able to travel independently between all local WPT sites (approximately 5 miles between all local sites).

GENERAL RESPONSIBILITIES:

Regular attendance is mandatory.

Maintain thorough, accurate, and legible documentation required fulfilling the cGMP requirement for the plant.

Be accountable for all documentation and production, which is his/her responsibility.

Have a working knowledge of scales, calibrations, and accuracy requirements.

Alert management to safety, quality, and equipment problems.

Have a basic understanding of materials handling to prevent contamination and to comply with cGMPs and customer requirements.

Obtain in:process product samples, when necessary, using proper sampling procedures;

Work and follow all safety procedures at all times and r


Fuente: Tiptopjob_Xml


Área:

  • Production - Manufacturing / Quality Assurance

Requisitos


Conocimientos:

  • Basic

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