Process Engineer

Tampa, FL

Posted: 04/08/2019 Job Number: JN -042019-10619
Process Engineer

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.

Title: Process Engineer
Location: Tampa, FL
Industry: Pharmaceutical
Hours: 1st Shift Monday-Friday, 8am-5pm
Salary: $28.00/hr.-$32.00/hr.
Employment Type: Up to 6 month contract

Environment: This client is one the world s leading suppliers to the pharmaceutical, biotech and specialty ingredients markets. We create products that support a healthier lifestyle and enhance ones quality of life. Isn t this a company you want to work for?

General Purpose
The Process Engineer is critical for helping to ensure that all GMP Manufacturing processes are designed and executed in a compliant and efficient manner. The Process Engineer is intimately involved with the technical and regulatory aspects of all assigned projects from inception to completion. The Process Engineer works cross-functionally within the entire organization to facilitate the successful development and completion of all projects, which ultimately meets the objectives and goals of the company.

Essential Duties
  • Provide technical support to all GMP Manufacturing processes.
  • Develop manufacturing processes in conjunction with internal Formulation Development group, client or combination thereof, to enhance and improve the manufacture of GMP drug products.
  • Attend applicable meetings in support of these projects. Recommend, specify and order equipment and parts in support of specific projects.
  • Write New Product Introductions (NPI) for all GMP Manufacturing Processes.
  • Write Master Batch Records and review executed batch records.
  • Write, review and approve Standard Operating Procedures (SOPs), specifications, and other procedures as required.
  • Recommend, specify, and order GMP manufacturing equipment including writing and execution of qualification protocols.
  • Process validation of commercial manufacturing processes. This includes writing, review, and execution of process validation protocols.
  • Responsible for writing deviations (utilizing Root Cause Analysis Tools) and performing CAPAs utilizing the Trackwise System.
  • Participate in project scheduling (including daily, short term, and long term) activities along with all applicable departments
  • Training of personnel with regards to applicable processes, batch records, internal procedures, etc.
  • Participate in safety processes and meetings as applicable. Potent Compound Handling: Specify and make recommendations with regards to handling of potent compounds. Duties may include design and specification of engineered controls and surrogate testing to verify performance. Make recommendations with regards to manufacturing and packaging processes, facilities, safety and hazardous material handling.
  • Maintain a positive, professional and confidential relationship with sponsors. Comply with all state and federal regulatory requirements and guidelines.
  • When necessary, act as liaison to public utilities, environmental and energy agencies. Assist in the inspection of construction activities to ensure conformance to specifications and suitability for occupancy.
  • Other applicable duties as assigned
Qualification
  • BS preferred in a science/engineering field of study. Extensive experience may substitute for educational requirements
  • Minimum 3 years within an FDA/GMP regulated environment; pharmaceutical is preferred (solid dosage is highly preferred).
  • Experience working within a commercial manufacturing environment
  • Strong ability to read and interpret technical documents such as Operations manuals, Master Batch Records, Protocols, Standard Operating Procedures.
  • Strong technical writing ability required in order to produce routine reports, equipment qualification protocols, master batch records, etc. Ability to speak effectively before groups Ability to solve detailed problems and deal with a variety of variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
  • The employee may lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision. While performing the duties of this job, the employee is regularly required to sit and talk or listen. The employee is frequently required to walk and spend long periods of time in a standing position. The employee is required to frequently use the hands and arms.
  • Able to multi-task a wide variety of duties and complete them according to pre-determined deadlines.
  • Must be team-oriented and self-motivated, with the ability to organize and achieve consensus and manage/direct negotiations.
  • Must be able to work in a deadline driven environment
Search words: process, Engineer, technical transfer, scale-up, manufacturing, master batch records, validation, IQ/OQ/PQ, FDA, GMP, pharmaceutical, solid dosage
EOE/ADA
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