Manufacturing Associate I (Production)

Job Description

Title : - Manufacturing Associate I

Location : Pearl River, NY

Duration : Contract until Oct 2026 (Possible extension after 1 year)

7am - 3 : 30pm : Mon-Fri (OT and Holidays as needed)

Downstream manufacturing role. GMP / Pharma manufacturing experience - must have at least one year. Aseptic / Gowned for 70%-80% of day. Must have good documentation for batch records. Potential for additional year extension.

RESPONSIBILITIES :

• In depth understanding of techniques and processes being executed on routine basis.
• Responsible for all aspects of downstream and buffer preparation including equipment preparation (CIP and SIP), appropriate use of raw materials and components (FIFO), weighing and dispensing of raw materials and intermediate solutions, material sampling for applicable analytical testing, filter integrity testing, etc.
• Responsible for the operation and maintenance of ancillary equipment such as pH / conductivity meters, turbidity meters, tube welder, tube sealer, peristaltic pumps, etc.
• Interacts with other departmental personnel to assist in resolving manufacturing quality issues.
• Technician should have the ability to manage and analyze manufacturing data.
• Ability to take initiative to identify issues, troubleshoot, propose solutions, and keep management informed.
• Ensure good documentation practices (GDP) in execution and reviews of production records.
• Responsible for all required cGMP training including additional training assigned by their manager.
• Participates in the cleaning of the cGMP facility in accordance with sanitary maintenance SOP.
• Follows established SOPs for the flow of materials, personnel, and equipment in and out of the cGMP facility.
• Work a flexible work schedule, weekends and holidays as required, and as needed by department.
• Work with Compliance regarding notification of deviations and CAPAs as they occur and provides information during investigations.
• Other duties as they are required.

REQUISITE EDUCATION / SKILLS :

MINAKSHI SANGWAN

Recruiting Lead - US Recruitment

O 732-339-3518

E Minakshi.sangwan@aequor.com