Manufacturing Associate III (Sterile Injectable Manufacturing)

Location: York, United States; on-site manufacturing facility

Company

BioTechnique, part of hirify.global, is a sterile injectable full-service CDMO providing formulation, compounding, fill-finish, and lyophilization services from IND applications through commercial production.

What you will do

• Perform aseptic and non-aseptic manufacturing operations for sterile injectable products, including compounding, filtration, formulation, and filling.
• Prepare, clean, sanitize, and sterilize production equipment, including CIP and SIP operations.
• Execute manufacturing instructions and maintain complete batch records, logbooks, SOPs, and other controlled documentation.
• Maintain aseptic gowning certification and controlled-environment conditions.
• Lead manufacturing activities, support commissioning and validation, and assist with new process formulation and validation.
• Initiate and support deviation investigations, root-cause analysis, corrective actions, and cross-functional quality activities.

Requirements

• Bachelor’s degree in Life Sciences or Liberal Arts, or equivalent experience.
• 5–7 years of manufacturing experience in an aseptic, FDA-regulated pharmaceutical facility.
• Experience with sterile injectable drug products, aseptic technique, formulation, filling, primary packaging, and aseptic processing.
• Experience reviewing and creating controlled documents, SOPs, and batch records.
• Ability to manage floor activities in the absence of a Supervisor and train Manufacturing Associates I and II.
• Willingness to work extended shifts and a variable schedule when required; strong communication, analytical, organizational, and mechanical skills.

Culture & Benefits

• Medical, dental, and vision coverage, with PSC paying 100% of qualifying employee medical premiums and 50% for qualifying dependents.
• 401(k) plan with matching contributions.
• Paid time off, sick time, and paid holidays.
• Education assistance, pet insurance, fitness benefits, financial perks, and discounts.
• Equal employment opportunity workplace with a focus on employee development and career growth.