Manufacturing Operator (Sat/Nights Shift)

Manufacturing Operator (Sat/Nights Shift)

Danbury, Connecticut

Full Time

Night Shift Hours: Alternating Wednesdays, but every Thursday, Friday and Saturdays from 6:00 pm - 6:30am.

Ideal candidate is someone who has previously worked in a production/manufacturing environment and comfortable wearing a Tyvek suit and respirator. Work schedule is 3 days one week and 4 days the next. The 4 day work week earns 8 hours of OT.

Executes quality and manufacturing procedures in order to meet production demands and regulatory requirements. Responsibilities include on-time manufacture of intermediate, semi-finished and finished pharmaceutical products that meet quality standards. Assists with establishing equipment operating specifications, standard operating procedures and improving manufacturing techniques. Assists with equipment maintenance, calibration and resolving technical issues.

Essential duties and key job responsibilities and essential functions.

• Works on assignments that are semi-routine in nature where some judgment is required in resolving problems and making routine recommendations. Exercises some judgment within defined practices and policies in evaluating criteria for obtaining results.
• May provide guidance on assignments to other lower-level personnel.
• Execute manufacturing operations as required by Manufacturing Records according to Current Good Manufacturing Practices and Standard Operating Procedures in a clean room environment
• Performs manufacturing area and equipment setup, cleanup and teardown and sanitization with supervision
• Operates manufacturing production equipment, under supervision, as required by Manufacturing Records and Standard Operating Procedures
• Performs in-process inspection and testing, under supervision, as required by Manufacturing Records and Standard Operating Procedures
• Accurately and completely documents manufacturing activities in appropriate Manufacturing Records, Controlled Forms Product Container Labels and Logbooks
• Verifies and documents manufacturing steps performed by other Manufacturing Associates as correct in Manufacturing Records and / or Logbooks
• Responsible for observing all Company, Health, Safety and Environmental guidelines
• Fully qualified and able to operate approximately 50% of manufacturing equipment.

Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary. Section III: Minimum qualifications to perform the job; specific skills, education, knowledge and job experience necessary to perform essential duties; physical requirements for job if any.

• High School/GED with minimum of 3 - 5 years related experience or the equivalent combination of experience and training.
• Must be willing and able to receive medical clearance to wear a respirator (i.e., Powered Air Purifying Respirator) for entire working shift.
• Must be physically able to gown and de-gown (including the use of a decontamination fogging shower) in up to three layers of clean room and potent compound facility gowning (i.e., Tyvek jumpsuit).

(Where reference is made to regulatory environment requirements and/or compliance this includes all applicable regulations i.e. FDA, ISO 13485, European requirements, etc.)