Lead Aseptic Manufacturing Specialist

PSC Biotech® Corporation; York (York County); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical, Dental, and Vision - PSC pays

Insurance options for EAP, Life, Short

401(k) and 401(k) matching

PTO, Sick Time, and Paid Holidays

Education Assistance

Pet Insurance

Fitness Benefits (gym discounts)

Financial Perks and Discounts

Job summary

PSC Biotech Corporation is seeking an experienced Manufacturing Associate III to contribute to aseptic and non-aseptic filling operations under GMP/ISO requirements. You will prepare equipment, execute formulation and fill activities, and maintain thorough production documentation.

You will collaborate with engineering, QA, and facilities, revise SOPs and batch records, and support tech transfer. Requires a Life Sciences degree and 5–7 years of aseptic manufacturing experience.

Qualifications

• Bachelor’s Degree in a Life Sciences or Liberal Arts field, or equivalent experience.
• 5–7 years of professional manufacturing experience in an aseptic, FDA-regulated facility.
• Ability to manage floor activities in the absence of the Supervisor.
• Experience in reviewing and creating controlled documents.
• Experience with sterile injectable drug products and aseptic technique.
• Familiarity with formulation, filling, primary packaging, and aseptic processing.
• Willingness to work extended shifts and a variable schedule when required.
• MS Office/Excel proficiency and strong communication skills.
• Self-motivated with the ability to complete multiple floor activities in a compliant manner.
• Strong attention to detail, organizational skills, and commitment to quality.

Responsibilities

• Maintain certification for aseptic gowning and demonstrate proper aseptic technique.
• Perform equipment preparation, including CIP and SIP operations.
• Execute manufacturing instructions for compounding, filtration, formulation, and fill activities.
• Adhere to verbal and written instructions when operating production equipment.
• Complete production documentation, batch records, and GDP-compliant forms.
• Perform room sanitization to maintain controlled environments.
• Identify, elevate, and document deviations; participate in investigations as needed.
• Execute routine operations, commissioning, and validation activities as assigned.
• Support engineering, warehouse, and facilities to build cross-functional skills.
• Revise and author SOPs and Batch Records.
• Assist with formulation and validation of new processes with tech transfer.
• Ensure sanitization and sterilization practices are followed for equipment and components.
• Maintain floor inventory and communicate schedule changes to the Supervisor.
• Perform additional duties as assigned.

Skills

MS Office

Excel

Strong communication

Attention to detail

Self-motivated

Education

Bachelor's degree in Life Sciences or Liberal Arts

Tools

MS Office/Excel

Job description

PSC Biotech Corporation is seeking an experienced Manufacturing Associate III to contribute to aseptic and non-aseptic filling operations under GMP/ISO requirements. You will prepare equipment, execute formulation and fill activities, and maintain thorough production documentation.

You will collaborate with engineering, QA, and facilities, revise SOPs and batch records, and support tech transfer. Requires a Life Sciences degree and 5–7 years of aseptic manufacturing experience.