Randstad R&D Technician in Fenton, Missouri

R&D Technician

job details:

  • location:Fenton, MO

  • salary:$58,000 per year

  • date posted:Thursday, January 10, 2019

  • experience:3 Years

  • job type:Permanent

  • industry:Professional, Scientific, and Technical Services

  • reference:27447

job description

R&D Technician

job summary:

Our client is in the process of growing their US operation and they will be hiring 50 new positions this year. Most of the positions will be in QA / QC and scientific areas. This very important of Technical Transfer Technician will work in the Technical Services Department and is responsible for operating machines, cleaning machines and all machine areas. The position holder is also responsible for performing documentation and following all safety and GMP rules / procedures.

location: Fenton, Missouri

job type: Permanent

work hours: 9 to 5

education: High School


Primary Responsibilities and Essential Functions of the Position:

  • Operate and maintain the machines in production area.

  • Provide input and support for protocol, Batch record and SOP preparation.

  • Perform the in process test analysis and Document in appropriate documents.

  • Review and revise the SOP and protocols.

  • Troubleshoot issues related to product quality, formulation and machine performance.

  • Perform job duties within the established guidelines of the Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP).

  • Complete all job related documentation accurately and timely.

  • Maintain high sanitary standards of cleanliness of work space, equipment, and materials at all times.

  • Perform cleaning duties of workspace to maintain sanitary conditions before, during, and after processing a new job.

  • Produce products that are defect-free, properly identified, and within the established standards of the master batch record.

  • Utilize hand tools, power tools, pallet jacks, and other tools as required to perform essential job duties.

  • Notify Supervisor or Manager if any discrepancies arise, such as but not limited to: safety, quality, operations, or health concerns.

  • Follow the proper Personal Protective Equipment (PPE) guidelines at all times.

  • Allow flexibility in assigned work schedule to meet business needs.

  • Perform other related duties and assignments, as requested by management.

  • Maintain a high standard of cleanliness of work space, equipment, and materials at all times.

  • Work with the team and management to design and manage studies for process development, process optimization, scale-up, and technology transfer. During execution, the individual will function as study lead person for production, managing all activities.

  • The individual is responsible for ensuring background CGMP processes are accounted for during the transition of a product into GMP production.

  • Independently manage multiple cross-functional projects that may require regulatory submissions.

  • Provide technical support for manufacturing activities including OOS/OOT investigation, process deviation impact, root cause investigation, process change and optimization

  • Write and revise SOPs, protocols and Master as part of process improvements.

  • Apply CGMP and CGDP to all areas of work.

  • Ensure manufacturing operators are adequately trained on the new processes prior to execution. Ensure that batch records are written effectively and capture all relevant information prior to execution.


Skills and Abilities Required:

  • Strong knowledge and experience with pharmaceutical manufacturing equipment.

  • Ability to multitask and writing documents.

  • Excellent communicators both written and verbal

  • Strong interpersonal skills

  • Strong problem solving skills

  • Proficient in general mathematics and basic algebra.

  • Candidate should have capability for lifting the material up to 50 lbs frequently.

  • Perform cleaning duties of workspace to maintain sanitary conditions before, during, and after processing a new job.

Minimum Education and Experience Required:

  • Qualified candidates must have a high school diploma or GED. College degree is preferable

  • 3-5 years of manufacturing experience in the pharmaceutical industry as technical person.

skills: GMP (Good Manufacturing Practice)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.