We are currently seeking a highly motivated and skilled individual to join our team as a Process Technician 1. As a Process Technician 1, you will be responsible for executing all phases of clinical and commercial packaging operations in accordance with SOPs and cGMP requirements.
In this role, you will be required to execute tasks outlined in the Batch Record, operate and assist in the set-up of packaging equipment, and assist in system challenges, in process inspections, and clinical start up activities. You will also be responsible for ensuring that your work area is in adherence to all safety standards and housekeeping standards outlined in governing SOPs, as well as cleaning and sanitizing equipment, tools, and rooms in accordance with SOPs.
To be successful in this role, you must possess a sense of urgency, be a team player, and have a proactive attitude in learning new tasks and demonstrating interest in self-improvement. You should also possess good basic mathematical skills and have an understanding of cGMPs.
As a valued member of our team, you will be expected to participate actively in regular meetings, achieve expected performance measures, and perform any additional duties as assigned by the Process Lead and/or supervisor that are in scope of Clinical and Commercial Operations.
If you possess the necessary attributes and competencies, we encourage you to apply for this exciting opportunity. Join our team today and take the first step towards a rewarding career in the pharmaceutical industry!
Requirements
To be considered for this job, candidates must be able to perform each essential duty satisfactorily and meet the following requirements:
- Possess a High School/Technical School diploma or a general education degree (GED) equivalent.
- Preferably have previous experience at a Pharmaceutical / Clinical or cGMP regulated facility, and some knowledge of production equipment and processes.
- Must be able to speak, read, comprehend, and write in English, as well as possess basic computer skills in email, Microsoft Office Work, and Excel.
- Communicate effectively with others.
- Be able to wear Personal Protective Equipment (PPE) such as safety shoes, safety glasses, respirators, and full hooded suits, as required by SOPs.
- Be able to work with Controlled Substances and pass a Criminal background check and drug screening.
- Have excellent dexterity, lift and/or move up to 50 pounds unassisted, and be able to bend, reach, stretch, and work in tight spaces.
- Be able to work in cold environments for extended periods of time and have excellent vision (with or without the assistance of glasses or contact lenses).
- Acknowledge that the physical demands of this job include standing for long periods, exposure to fumes or airborne particles, and working near moving mechanical parts, with a moderate noise level in the work environment.
Benefits
The above qualifications are intended to describe the general nature and level of work performed by individuals assigned to this classification. However, this is not an exhaustive list of all duties, responsibilities, qualifications, and skills required for this job. Candidates with disabilities may request reasonable accommodations, which must be processed through and approved by Human Resources.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. High School Diploma; Bachelor s Degree preferred. 1 -3 years experience in shipping and warehousing, pharmaceutical and international preferred. Demonstrated ability to work in supply chain management, handle multiple tasks simultaneously, and meet critical timelines. Strong oral and written communication skill to communicate with the team, peers, management, and external contacts. Ability to interpret cGMPs, FDA, DEA, OSHA, and IATA Regulations, and ISO guidelines. Working knowledge of personal computers and Microsoft Office Products, including Word, Project, and Excel