This is a 3rd shift role that includes an additional hourly pay shift differential

Performs functions relating to the processing of drug products; consistent with established Current Good Manufacturing Practices (cGMP), customer requirements and in conjunction with all Standard Operating Procedures (SOP). Responsible for the safe and efficient execution of their job duties, while ensuring product compliance to established standards.

Responsibilities

• Operate equipment for one or more production processes: Glatt fluid bed processor, Granulation, Blending, Compression Coating, Imprinting, Banding and Encapsulation.

• Perform machine changeovers, cleaning, & set up as required.

• Troubleshoot and make appropriate adjustments to maintain production specifications.

• Ensure adherence to quality standards during the manufacturing process.

• Complete manufacturing documents, ensuring accuracy and completeness.

• Maintain compliance at all times with appropriate SOPs and cGMPs.

• Perform duties through proper, safe use of equipment following all OSHA regulations and Equipment Manuals.

Work Conditions:

Manufacturing/Production/Laboratory environment Environmental related to manufacturing/production/Laboratory environments:

Noise: Sufficient noise, either constant or intermittent, to cause marked distraction or possible injury to sense of hearing.

Fumes: Smoky or vaporous emissions, usually odorous, thrown off as the result of combustion or chemical reaction.

Odors: Unpleasant smells.

Gases: Examples include carbon monoxide and helium.

Dust: Airborne particles of any kind, such as textile dust, wood, and silica.

Hazards: Conditions where there is danger to life, health or bodily injury such as closeness to moving mechanical parts; working on scaffolding and high places; exposure to burns, radiant energy, explosives, toxic chemicals, and electric shock. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to use hands to handle or feel and talk or hear.

The employee is frequently required to stand, walk, sit and stoop, kneel, crouch, crawl, push, and bend.

Must be capable of bending and lifting, moving and/or carrying up to approximately 50 - 75 pounds.

Must have the ability to navigate office, lab, warehouse and/or plant floor working environments, stand, ambulates, and reaches.

Must have the ability to wear applicable personal protective equipment utilized at the site, including but not limited to respirators, safety glasses/goggles, and safety shoes.

Qualifications:

• High School/Trade School/Vocational School Diploma, GED, or equivalent

• Minimum of 1- 2yearsof Production/Manufacturing experience including solid experience in primary production process.

• Experience in Glatt fluid bed processor, Granulation, Blending, Compression Coating, Imprinting, Banding or Encapsulation

• Forklift or other related equipment certification a plus

• Strong Troubleshooting skills

• Good knowledge of cGMP and other pharmaceutical regulatory requirements

• Good knowledge of Occupational Health & Safety procedures

• Good Math and Computer Skills including MS Office and some experience with SAP helpful

• Strong Interpersonal & communication (both verbal & written)

• The requirement for English language proficiency for this job role is Basic A2 (comparable to Global CEFR Basic A2) level based on the Common European Framework of Reference for Languages (CEFR).

Disclaimer:

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.