Manufacturing Technician/Chemical Operator

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 ofactive pharmaceutical ingredients, intermediates, and/or medical devices. These responsibilitiesinclude using equipment for the assembly and processing tasks to produce finished productsaccording 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 processeswithin area of assignment and a working knowledge of manufacturing equipment andchemical processing principles.• Sets up, operates and cleans production equipment used to produce intermediate orfinished products for Active Pharmaceutical Ingredients, medical device raw materialcomponents, or other products as directed; completes all associated support activitiesin the production of these products.• Follows and accurately completes batch records/logs, SAP transactions and otherdocumentation associated with all production processes to ensure efficient operationsand 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 guidelinesusing material handling equipment and additional assistance as required.• Performs area safety inspections to identify safety hazards and report findings inaccordance with company protocols.• Performs all duties with attention to quality, safety and environmental matters includingwearing appropriate personal protective equipment, recognizing, reporting, andappropriately 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 andtechniques.• Demonstrates adherence to safety procedures by monitoring personal and peerbehaviors, work environment and housekeeping.• Responsible for handling controlled substances in compliance with applicable State andlocal 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 asDCS/PLC controls and failure issues and recognizes abnormal operation ofinstrumentation.Participates on site investigative teams and where applicable, in VSAs, PSSRs, PHAs, andbehavioral safety assessments; Corrects and/or mitigates findings from assessments.• Connect inclusively within the department, with other departments, and within thecompany to address customer needs.• Shape the future through innovation by inspiring new ideas, trying new things, anddemonstrating resilience and agility to adapt to change.• Grow by developing self and others to reach goals by engaging in open and honestconversations, managing energy, and taking ownership for outcomes.Additional position requirements:• Assumes responsibility for the environmental effects of work performed and for theidentification and recording of environmental problems as they arise.• Follows all applicable aspects of the site Environmental Management System as itpertains to normal job duties.• Partners with Supervisor and Quality Department in making recommendations tomodify existing procedures, instructions and batch logs within the assigned productionprocesses as well as developing new procedures, instructions, and batch logs.• Carry out duties in compliance with all state and federal regulations and guidelinesincluding FDA, EPA, OSHA and DEA. Maintain compliance with all company and sitepolicies 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 toassure a continuous state of inspection readiness.• Continuously looks for ways to simplify or improve products, services, systems, andprocesses to achieve business goals, e.g., improve yield, cycle time, quality, andproductivity.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 thatcomplies 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 applicationsas instructed and use software applications for mail, word processing, spreadsheets andother 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.