Manufacturing Associate II (Sterile Injectables)

Location: York, United States

Company

BioTechnique is a sterile injectable full-service contract development and manufacturing organization providing formulation, compounding, fill-finish, and lyophilization services from IND applications through commercial production.

What you will do

• Perform routine and critical aseptic and non-aseptic manufacturing operations for sterile injectable products.
• Prepare equipment through CIP and SIP operations, and perform cleaning, sanitization, and sterilization activities.
• Execute compounding, filtration, formulation, filling, and primary packaging activities according to manufacturing instructions and SOPs.
• Complete batch records, logbooks, forms, and other production documentation in accordance with Good Documentation Practices.
• Identify, escalate, and document deviations; participate in investigations, commissioning, validation, and introduction of new manufacturing processes.
• Support engineering, warehouse, and facilities activities, maintain floor inventory, revise controlled documents, and assist with training Manufacturing Associate I employees.

Requirements

• Associate or bachelor's degree in life sciences, liberal arts, or equivalent experience preferred.
• 2–5 years of professional manufacturing experience in an FDA-regulated pharmaceutical facility.
• Experience reviewing and creating controlled documents, including SOPs and batch records.
• Experience with sterile injectable drug products, aseptic technique, formulation, filling, primary packaging, and aseptic processing.
• Ability to work extended shifts and variable schedules when required.
• Strong communication, analytical, organizational, prioritization, mechanical aptitude, attention to detail, and commitment to quality.

Culture & Benefits

• Medical, dental, and vision insurance, with PSC paying 100% of qualifying employee medical premiums and 50% for qualifying dependents.
• Employee assistance programs, basic life insurance, short- and long-term disability coverage, and other insurance options.
• 401(k) plan with matching contributions.
• Paid time off, sick time, and paid holidays.
• Education assistance, pet insurance, fitness benefits, and financial discounts.