Process Development Engineer in Columbia, SC at Apex Life Sciences

Date Posted: 2/9/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Columbia, SC
  • Job Type:
    Engineering
  • Experience:
    Not Specified
  • Date Posted:
    2/9/2018
  • Job ID:
    817770

Job Description


Job Description:

Process Development Engineer II is responsible for designing and implementing dispensing, formulation, filling and packaging processes, equipment, and plants (from lab scale and pilot to fully operational) to achieve the production goals of the organization.  Identifies and develops process and equipment needed to produce specific products, parts, and components.  The engineer is familiar with standard pharmaceutical manufacturing concepts, practices, and procedures.  The engineer relies on limited experience and judgement to accomplish goals and performs tasks with minimal supervision.

Responsibilities:

Perform actions as directed by the Sr. Director, including but not limited to the following areas:

  • Purchase of goods and services.
  • Product Development Life Cycle, Planning, Initiating and Development.
  • Define the sterile boundary of a process and an examination of the sterile process with media challenges.
  • Ensuring new or revised formulation, filling and packaging process follow cGMP.
  • Create or revise new product documentation as required such as development plans, lab batch protocols, process flows, procedures, work instructions, batch records, and bill of materials.
  • Equipment Cleaning Assurance – Cleaning Lifecycle, Concepts of Cleaning, Determination of Cleaning Limits, Cleaning Cycle Studies and Verification, Cleaning Agent Determination, Cleaning Validation
  • Create process studies of formulation and filling. 
  • Initiate product life cycle through development plans and change controls.
  • Assist in the creation or revision of new product documentation as required such process flows, procedures, batch records, and bill of materials.
  • Assist in risk assessments.
  • Work with internal and external experts and the customer to develop product specifications, testing requirements, and process descriptions.
  • Perform process Failure Mode and Effects Analysis.
  • Coordinate resources towards completion of tasks in the project management plan.
  • Execute process development activities related to the batch manufacturing including process sampling, and studies of equipment capability, cleaning cycles, and sterilization cycles.

Qualifications:

  • Four year college degree in Chemical Engineering, Science, or directly related field
  • 0 to 3 years of experience in manufacturing.  3-5 years of experience in Pharmaceutical manufacturing a plus.
  • Strong interpersonal/group communication skills
  • Knowledge of cGMPs/CFR standards and guidelines
  • Proficient with MS Office products, Visio and CAD.