Technical Operator

Technical Operator (2nd Shift)

Glen Rock, PA

Qualifications

Requires an Associates degree in a technical competency or 1-2 years of mechanical/maintenance work on packaging equipment

Capable of learning practical application of technical skills in areas including but not limited to LEAN manufacturing principles, design control, validation, experimental design, etc

Excel, Word, PowerPoint, Outlook, Statistical software package capability

Ability to effectively organize thoughts, information and data; can articulate and convey them (oral and written) concisely and clearly to others

Ability to manage several priorities simultaneously

Time flexibility to occasionally work extended hours as business demands

Must be able to travel as needed to support the business (<25%)

Work environment may involve moderate risks or discomforts requiring special safety precautions, e.g., working around moving parts, machines, chemical irritants; may be required to use personal protective equipment such as masks, uniforms, blues, hairnets, gloves, safety glasses/goggles, shields, etc

Ability to function effectively with others in a team environment

Benefits

The training is provided on 1st shift

Responsibilities

Must be able to work 2nd shift hours

Responsible for assisting in developing, scaling up and validating processes used for producing specialty drug delivery products in a manner compliant with 21CFR211 and all other relevant regulatory requirements on the packaging lines

Work with the manufacturing and process engineers to develop modified and new processes for producing specialized drug delivery therapeutic products

Works in close collaboration on cross-functional teams with Engineering, Operations, and Quality to accomplish successful outcomes

Will work on the packaging line as needed

Provides oversight to packaging process, including spending significant time on the line and monitoring the process

Performs a variety of technical line tasks with Engineering and Operations guidance, which include but are not limited to the execution of experimental and validation protocols for packaging in compliance with 21CFR211 Regulatory standards

Contributes to designing experiments, conducts experiments, collects data and performs data analysis and interpretation

Generates reports and makes recommendations based on sound data interpretation

Contributes to generating cleaning processes and change over requirements

Contributes to design records required to support product development and commercial production

Accurately performs work assignments and collects information for computer data analysis

Effectively communicates and interacts with other associates and customers

Participates in problem-solving efforts

Proactively works to develop foundational knowledge base on relevant process technologies

Develops and maintains awareness of business strategies and plans

Conducts all work activities in a safe, responsible and professional manner consistent with all Company Policies, Quality Systems Requirements and Relevant Regulatory Standards (e.g. 21CFR211)

Supports deviation investigations; develops and implements preventative actions

Participates in training and supports the designs for equipment trainings

Supports the data collection for the design of equipment recipes for operation

Acts as line lead on the packaging line for manufacturing activities

Performs other duties and responsibilities as assigned