Pharmaceutical operator job description

Job Title
Pharmaceutical Operator I

Requisition

JR000012620 Pharmaceutical Operator I (Open)

Location

Raleigh, NC (Pharma) - USA033

Additional Locations

Job Description

SUMMARY OF POSITION:
This position is responsible for operating large scale manufacturing equipment to produce bulk organic chemicals in accordance with Company standards and operating procedures. He/she will be responsible for reports and documentation. Must be able to pay attention to detail due to the nature of chemicals and environment he/she will be working in on a daily basis.

ESSENTIAL FUNCTIONS:

Operates in a regulated environment and complies with all cGMP and OSHA regulations applicable to manufacturing responsibilities. This includes wearing appropriate personnel protection equipment (PPE), understanding and following all applicable standard operating procedures, work instructions, and standard work practices applicable to job responsibilities Operates and monitors dryers, sifters, and other miscellaneous equipment through manual operations, panel boards, indicators, PLC displays, and DCS screens following applicable batch records, procedures and good documentation practices Packages, weighs, samples, and labels finished and intermediate products following applicable procedures and good manufacturing practices Maintains detailed operating reports and logs, including notes on problems and records on added weights, volumes, measured temperatures, pH levels, pressures, and flow rates following applicable procedures and as directed by supervisor Delivers samples to laboratory and retrieves operating supplies from storeroom Cleans and maintains work area, process equipment, tools and safety supplies according to regulatory and Company standards and operating procedures.Must participate in Emergency Response Team (Hazmat Team, First Responders, First Aid & CPR) Other duties as assigned by Management

DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
Monitors environmental and safety devices (scrubbers, ruptured discs, etc.) to insure that the equipment is functioning properly.Operates fork lifts, hoists, and other material handling devices to physically move bulk raw materials, WIP, and packaged goods to and from pick-up points Participate in various employee involvement teams and committees, such as Area/Site Safety Teams, kaizen events, Hazmat and/or Cost Savings Teams, to improve the workplace, increase efficiency, and improve productivity

MINIMUM REQUIREMENTS:
Education:
High School Diploma, GED, or equivalent required.
Associate or Technical degree preferred.
Experience:
Previous GMP/ISO manufacturing experience preferred
Skills/Qualifications:

Skills/Competencies:

Other Skills:
Must be able to read and follow detailed instructions and procedures, and effectively communicate in both verbal and written formats.
Must be able to perform basic math.
Must have a working knowledge of chemical processing equipment and associated safety requirements.
Possess sound decision making skills.
Action Oriented, Informing, Computer Skills (MS Office and E-mail), Problem Solving, and Teams
Must work in a team environment to cover work stations during breaks and lunches
Must be able to wear the required Personal Protective Equipment (PPE) required for the job or task.
Sound decision making skills.
Action Oriented, Informing, Computer Skills (MS Office and E-mail), Problem Solving, and Teams

RELATIONSHIP WITH OTHERS/ SCOPE:
Performs diversified duties following standard procedures and under the direction of a production supervisor or lead operator. Requires a high level of safety awareness and ability to determine when equipment is not performing to standards or expectations.Responsible for proper operation of processing equipment to ensure optimum production of high quality products. Mistakes and errors normally result in unacceptable product and or mechanical equipment damage. As a result, impacts our product status in the market place.Understands the misuse of processing equipment could result in serious injuries to self and others due to the potentially dangerous nature of the equipment and the chemicals being processed.No direct responsibility for the work of others; however, the team approach is emphasized in order to cover work stations during breaks and lunches. Furthermore, the “buddy system” for training new operators creates additional responsibility.

WORKING CONDITIONS:
The plants open-air construction exposes operators to the normal year-round outside climate. Some relief from the elements is available in the control rooms and break area.Dirty conditions and chemical fumes are occasionally present in the work areas.Must handle average to heavy weight materials by hand. Material handling devices (e.g., hand truck, for truck, and conveyors) are used when possible but use of proper lifting and movement techniques is necessary to prevent injury.Must be able to physically climb stairs and evacuation ladders, rolling drums, lifting and pouring bags of raw materials, driving forklifts, climbing and entering reaction vessels and perform first aid.Injuries could result from spills or leaks of corrosive flammable, and toxic material, all of which are normally handled in the plant Must be able to work rotating 12 hours/day shift and occasional overtime as needed.

DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Pharmaceutical Operator, are to:

* Ensure safe work environment by following all safety procedures, workplace standards and company guidelines, and ergonomic rules, including proper use of personal protective equipment (PPE), standard operating procedures (SOPs) applying to a particular process or area, Current Good Manufacturing Practices (cGMPs), Occupational Safety and Health Administration requirements (OSHA), Lockout Tagout.
* Work with the other pharmaceutical operators and supervisors in assigned area to establish priorities and meet deadlines, meet the production schedules outlined by team and/or supervision.
* Maintain, clean, and organize work area and participate in safety improvement projects, properly dispose of waste product and containers.
* Dispense components, operate, clean, set-up, changeover and maintain equipment and rooms to manufacture products, clean and maintain process equipment which may include, but not limited to tanks, filler, pumps, blenders, mills, presses, coating pans, etc.
* Assist with technical troubleshooting and preventive maintenance tasks as needed and trained, take action to safely reduce equipment setup and changeover times, initiate and establish equipment operating parameters to maximize production, while meeting all product specifications.
* Ensure product quality by performing in-process checks, complying with cGMPs, being alert for unacceptable quality of incoming and outgoing materials, initiating quality improvements, and participating on quality improvement projects, communicate quality and other noncompliance issues to supervision in a timely manner.
* Record accurately on the appropriate documents the process/manufacturing steps, production results, equipment in-process checks, samplings, cleanings, ingredients used, and any other required cGMP information, maintain daily production sheets and time sheets for team.
* Review and approve work output for team members by using validated methods.
* Perform work, on personal computer (i.e., Business Operating Systems, read and respond to electronic mail in a timely manner, Microsoft Software, etc.), complete, maintain, and update production documentation (both electronic and paper) to perform material movements, material take-outs and yield determinations by following SOPs and utilizing systems as required such as Systems/Applications/Products (SAP), Manufacturing Execution Systems (MES), Electronic Batch Records (EBRs), etc.
* Operate motorized and non-motorized material handling equipment for assigned stocking operations as well as stand up and sit-down fork trucks as needed.
* Take ownership of training and learning to develop high performance competencies such as technical skills, communication skills, and skills to build a team-oriented culture (i.e., take ownership of training records for self-development and submit to supervision in timely manner, training team members, motivating and supporting team members, sharing knowledge to continuously improve the process, etc.).
* Train other pharmaceutical operators on equipment and processes as needed.
* Inform department Administrative Assistant when to order supplies as needed.
* Coordinate the utilization of outside contractors and vendors as needed.
* Participate in on-going medical surveillance programs as required.
* Assign to Turret Cleaning/Assembly/Maintenance area of manufacturing.
* Develop technical skills and abilities to operate and maintain tablet press equipment, taking ownership of the Turret Management process across a three shift (24 hour) operation.
* Troubleshoot and diagnose tablet press equipment issues and perform preventive maintenance tasks.
* Act safely when cleaning tablet press, as well as reducing equipment setup and changeover times with tablet press.
* Initiate and establish tablet press operating parameters to maximize production, while meeting all product specifications.
* Perform other duties as trained and assigned.

WHO YOU ARE

Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:

Required Qualifications:

* High School Diploma or GED with At least six months experience using motorized and non-motorized material handling equipment or at least six months experience using automated inventory system or equivalent computer systems (i.e., SAP, MES, Microsoft Software, etc.).
* Excellent written and verbal communication skills in English.
* Demonstrated ability to successfully changeover/set up multiple pieces of packaging or manufacturing equipment and troubleshooting skills.
* Demonstrated ability to work safely in a production environment.
* Demonstrated ability to read/interpret/follow instructions regarding workplace documentation, such as SOP's, Operator Manuals, Work Instructions, etc.
* Be able to demonstrate a good mathematical aptitude in addition, subtraction, multiplication, division, and metric system.
* Experience working in a Good Manufacturing Practices (GMP) or
* standard operating procedures (SOP) environment.
* Good PC Skills, including use of e-mail, attaching documents to e-mail, previous experience using electronic databases and online tools required (i.e., but not limited to, Lotus Notes database, Employee Self-Services on-line tools, automated inventory tracking system, etc.).
* Be willing to work overtime as required, based on production demands.
* Assigned to Turret Cleaning/Assembly/Maintenance.
* Demonstrated ability to work independently as well as an effective team member to support schedule attainment demands, including prioritizing and time management skills.

Preferred Qualifications:

* Be physically able to operate a forklift truck, forklift truck experience.
* Manufacturing experience.
* Demonstrated ability and skills to successfully troubleshoot/diagnose, changeover, operate, clean, and maintain Tablet Press.

Bayer is an Equal Opportunity Employer/Disabled/Veterans

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. IMPORTANT NOTE for POTENTIAL US CANDIDATES: Bayer expects its employees to be fully vaccinated against COVID-19. Bayer active employees are also expected to disclose their vaccination status and if fully vaccinated, provide proof of vaccination status to Occupational Medicine. Bayer defines fully vaccinated in alignment with CDC which is two weeks after completing the two-dose vaccine regimen or two weeks after completing the one-dose regimen. Additionally, Bayer employees are also required to comply with state, local and customer requirements. Division: Consumer Health Reference Code 736501 Functional Area: Production&Manufacturing