Chemical Manufacturing Operator

External Job Description

Our medical device client is seeking an experienced Chemical Manufacturing Operator to join their new business unit. The team is focused on running pilot-scale reactors to evaluate process improvements and assess raw materials for chemical process changes. This is an excellent opportunity for professionals with a background in chemical manufacturing operations, particularly within the medical device or pharmaceutical industries, to play a pivotal role in scaling up our site operations.

Essential Job Duties And Responsibilities

The Manufacturing Operator performs duties related to the preparation and manufacture of

active pharmaceutical ingredients, intermediates, and/or medical devices. These responsibilities

include using equipment for the assembly and processing tasks to produce finished products

according to established specifications and in accordance with standard operating procedures,

as regulated by quality, environmental, and safety agencies (FDA, EPA, OSHA, DEA, etc.).

• Possesses a basic understanding of a limited number of chemical production processes
  
  

within area of assignment and a working knowledge of manufacturing equipment and

chemical processing principles.

• Sets up, operates and cleans production equipment used to produce intermediate or
  
  

finished products for Active Pharmaceutical Ingredients, medical device raw material

components, or other products as directed; completes all associated support activities

in the production of these products.

• Follows and accurately completes batch records/logs, SAP transactions and other
  
  

documentation associated with all production processes to ensure efficient operations

and compliance with cGMP and standard operating procedures.

• Demonstrates effective operation of dryers, centrifuges, mills, reactors, water systems,
  
  

DCS and PLC control systems and appropriately responds to alarms and interlocks.

• Transports materials of varying weight in accordance with established safety guidelines
  
  

Using Material Handling Equipment And Additional Assistance As Required.

• Performs area safety inspections to identify safety hazards and report findings in
  
  

accordance with company protocols.

• Performs all duties with attention to quality, safety and environmental matters including
  
  

wearing appropriate personal protective equipment, recognizing, reporting, and

appropriately responding to hazards in the work area (spills/accidents/near misses),

always maintaining proper housekeeping, and properly labeling and storing chemicals.

• Completes process sampling requirements following applicable schedules and
  
  

techniques.

• Demonstrates adherence to safety procedures by monitoring personal and peer
  
  

behaviors, work environment and housekeeping.

• Responsible for handling controlled substances in compliance with applicable State and
  
  

local law and client requirement.

• Ensures products are correctly manufactured and removes defects as required.
• Compiles records and reports on quality inspection results.
• Performs basic troubleshooting on equipment such as dryers and centrifuges as well as
  
  

DCS/PLC controls and failure issues and recognizes abnormal operation of

instrumentation.

Participates on site investigative teams and where applicable, in VSAs, PSSRs, PHAs, and

behavioral safety assessments; Corrects and/or mitigates findings from assessments.

• Connect inclusively within the department, with other departments, and within the
  
  

company to address customer needs.

• Shape the future through innovation by inspiring new ideas, trying new things, and
  
  

demonstrating resilience and agility to adapt to change.

• Grow by developing self and others to reach goals by engaging in open and honest
  
  

conversations, managing energy, and taking ownership for outcomes.

Additional Position Requirements

• Assumes responsibility for the environmental effects of work performed and for the
  
  

identification and recording of environmental problems as they arise.

• Follows all applicable aspects of the site Environmental Management System as it
  
  

pertains to normal job duties.

• Partners with Supervisor and Quality Department in making recommendations to
  
  

modify existing procedures, instructions and batch logs within the assigned production

processes as well as developing new procedures, instructions, and batch logs.

• Carry out duties in compliance with all state and federal regulations and guidelines
  
  

including FDA, EPA, OSHA and DEA. Maintain compliance with all company and site

policies and procedures.

• Completes all regulatory training as assigned (cGMP, ISO14001, OSHA, DEA, etc.)
• Completes Operator Training Program according to established guidelines.
• Accountable to ensure the Area is prepared for internal and external audits.
  
  

Participates in audits as necessary. Drives documentation and housekeeping practices to

assure a continuous state of inspection readiness.

• Continuously looks for ways to simplify or improve products, services, systems, and
  
  

processes to achieve business goals, e.g., improve yield, cycle time, quality, and

productivity.

Education

• High school diploma or GED.
  
  

Experience And Skills

• Minimum of 2 years experience in a related regulated manufacturing industry
• Basic math skills required.
• Ability to communicate and effectively work as part of a team.
  
  

Preferred

• A minimum of 6 months of work experience in chemical, pharmaceutical, or industry that
  
  

complies with cGMP environment.

• Operating skills of manufacturing equipment, tools, and hand/forks trucks preferred.
• Knowledge of DCS and SAP systems.
• Basic PC navigation such as the ability to enter data into programs/software applications
  
  

as instructed and use software applications for mail, word processing, spreadsheets and

Other Job Specific Needs Highly Preferred.

• Be available for overtime work on a scheduled or emergency basis.
  
  

Schedule

• During pilot runs: Shift work required to maintain 24-hour reactor operation.
• Non-pilot weeks: Regular daytime schedule.