Job Title

Pharmaceutical Operator 1

Requisition

JR000014055 Pharmaceutical Operator 1 (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, mills, 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.

• 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.

• Performs Lock Out/Tag Out (LOTO) independently.

• 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.

Mallinckrodt is a global specialty p harmaceutical business that develops, manufactures, markets and distributes specialty pharmaceutical products. Areas of focus include therapeutic drugs for autoimmune and rare disease specialty areas like neurology, rheumatology, nephrology, ophthalmology and pulmonology; immunotherapy and neonatal respiratory critical care therapies; and analgesics and central nervous system drugs. The company's core strengths include the acquisition and management of highly regulated raw materials; deep regulatory expertise; and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing.

To learn more about Mallinckrodt, visit www.mallinckrodt.com.

Mallinckrodt Pharmaceuticals (“the Company”) maintains a continuing policy of non-discrimination in employment. The Company is an equal opportunity employer and complies with all applicable laws prohibiting discrimination based upon age, ancestry, color, religious creed (including religious dress and grooming practices), disability (mental and physical), marital status, medical condition, genetic information, military and veteran status, national origin (including language use restrictions), political activities or affiliation, race, sex (including pregnancy, child birth, breastfeeding and medical conditions related to pregnancy, child birth or breastfeeding), gender, gender identity and gender expression, sexual orientation, as well as any other category protected by law. Furthermore, it is our policy to provide equal opportunity to individuals with disabilities and protected veterans in all phases of the employment process and in compliance with applicable federal, state, and local laws and regulations on every location in which the company has facilities. This policy of non-discrimination shall include, but not be limited to, the following employment decisions and practices: recruiting, hiring; promotions; demotions or transfers; layoffs; recalls; terminations; rates of pay or other forms of compensation; selection for training, including apprenticeship; and recruitment or recruitment advertising.

Mallinckrodt Pharmaceuticals is required to report certain payments or transfers of value (such as expense reimbursement, meals, transportation) made to U.S.-licensed healthcare professionals in compliance with the federal Physician Payment Sunshine Act (i.e. Open Payments) and certain state laws.