FSP Packaging Preparation Technician

Thermo Fisher Scientific•Raleigh, NC

7d•Onsite

About The Position

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Job Purpose: Produce clinical trial materials (CTM) for domestic and international clinical trials. Responsible for performing label printing/inspection and documentation preparation activities to meet the required GMP quality standards. This is a full-time, fully onsite role (M-F, 1st shift) at our Zebulon, NC location. This role supports our Functional Service Provider (FSP) model.

Requirements

Advanced Degree with no prior experience required, or Bachelor's Degree plus 2 years of experience in packaging/labeling engineering, preferably in pharmaceutical, medical device, or regulated industries
Strong knowledge of packaging materials, equipment, and label printing technologies
Expertise in GMP requirements and regulatory compliance standards
Experience with packaging validation and documentation (IQ/OQ/PQ)
GMPs (current Good Manufacturing Practice) and other applicable regulatory requirements
Understanding of the development process and demonstrated experience in the clinical supplies area is required.
Knowledge of GMP label creation and packaging operations to support clinical trials.
Ability to work independently with minimal supervision.
Ability to prioritize tasks and work in a flexible manner with some supervisory input.
Detailed oriented.
Basic PC operation (Email, Windows, word processing, database, spreadsheet applications)
Ability to write documents
Good interpersonal skills.
Ability to adhere to written instructions (i.e. follow the rules and guidelines of the department).
Developing sound judgment, decision-making skills and strong organizational skills.
Beginning to influence others.
Must exhibit strong communication, negotiation, and interpersonal skills.
Ability to function on a high-performance team.
Ability to listen and follow verbal instructions.
Ability to perform trouble shooting and problem solving with supervision.
Ability to follow-up and evaluate problems appropriately.
Ability to double-check the work of others for accuracy.
Ability to build team spirit.
Participate and support implementation of change.

Nice To Haves

Preferred Fields of Study: Packaging Engineering, Mechanical Engineering, Chemical Engineering, or related technical field

Responsibilities

Produce clinical trial materials (CTMs) in accordance with packaging orders to achieve useful results, ensuring compliance with applicable regulations.
Identify problems and deviations, and make recommendations on solutions to ensure deadlines are met.
Print and inspect clinical labels for use in clinical trials, including bay set-up and line clearance.
Prepare data entry for primary or secondary packaging documentation in accordance with GMPs and Standard Operating Procedures.
Ensure high levels of attention to detail and data accuracy to documentation.
Use systems critical to the delivery of labels and packaging documentation (e.g. ClinPro, PTMS, COMET, or future applicable systems), and recognize when it is necessary to seek support to resolve systems issues.
Ensure routine tasks (i.e. Print head checks) are performed in accordance with their required schedule.
Execute assigned tasks and activities with high quality and attention to own and other’s safety.
Ensure that any non-standard activities that occur during label or documentation preparation are appropriately raised to team coordinator or supervisor (e.g. Deviations).
Act as first line resolution of quality, productivity, and safety issues.
Verify equipment set up including quality critical settings.
Complete and verify reconciliations of labels.
Anticipate/recognize potential problems with equipment/materials and initiate action to address or prevent problems.
Identify and begin to interpret problems in processes and/or in results and communicate them to his/her supervisor.
Consult with supervisor when difficulties arise that cannot be readily resolved.
Work with trainees to complete training modules and assess training competency of specific activities.
Participate in safety risk assessments.
Identify and participate in delivery of continuous improvement opportunities in order to improve quality, productivity, and safety.
Request labels for the on-time completion of jobs.
Participate in Quality Investigations as a technical expert in a manner subject to L2/L3/L4 scrutiny, when appropriate.
Participate in local and regulatory audits (compliance and safety).
Write and obtain approval of observation reports.
Learn to present concise summaries of own activities in group settings.
Participate on inter-department project teams to meet company milestones and objectives.
Prepare brief oral or written summaries of results with interpretation for “projects”.
Assist in primary and secondary packaging floor operations as needed (with appropriate training).