Job Description

Job Description

Job Description

Wilmington PharmaTech (WPT) is looking for a Process / Production Engineer with cGMP 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 (GMP) 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. A qualified applicant should have the skills or previous knowledge of the below tasks:

• 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 cGMP setting.
• Able to define and carry-out equipment training programs.
• Create, read and understand batch records, SOP’s and related documents
• Comply with all cGMP requirements as directed by the Quality department and management.
• 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 basic understanding of materials handling to prevent contamination and to comply with cGMP’s and customer requirements.
• Follow all safety procedures at all times and report any potential safety hazards to on-site safety staff or to team leader.
• Experience with potent compounds (HPAPI) is a plus.
• Must be able to demonstrate in-depth understanding of technical equipment, Quality Systems and the interface between equipment and the associated automation.
• Understanding of facility technology, system troubleshooting using root cause analysis tools, CAPA’s and change controls highly preferred.
• Other duties as assigned.

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