Manufacturing Associate II

PSC Biotech • York, PA

1d • Onsite

About The Position

BioTechnique is a sterile injectable full service CDMO providing cytotoxic and therapeutic sterile injectable fill-finish services. From IND applications through commercial scale production, we provide formulation and compounding, fill-finish, and lyophilization services for a wide variety of liquid injectables. BioTechnique utilizes our team’s expertise to create a process design for our clients’ products that best suits their needs.

With operations spanning the globe and featuring a multi-cultural team, BioTechnique is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.

We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered a compensation and benefits structure that rewards you but also be provided with the tools that will help you grow and learn.

At BioTechnique, it’s about more than just a job—it’s about your career and your future.

Requirements

• Associates or Bachelors Degree in Life Sciences/Liberal Arts field or equivalent experience preferred
• 2-5 years of professional manufacturing experience in an FDA Regulated Pharmaceutical facility
• Experience in reviewing and creating controlled documents
• Experience with sterile injectable drug products and well versed in aseptic technique
• Familiarity with formulation, filling, primary packaging, and aseptic processing
• Willingness to work extended shifts and a variable schedule when required
• Skilled in MS Office/Excel tools
• Excellent communication skills, verbal and written.
• Self-motivatedl with the ability to complete multiple floor activities in an effective and compliant manner
• Strong attention to detail, organizational skills, and commitment to quality.
• Proven ability to plan and prioritize complex activities
• Strong analytical skills and mechanical aptitude to identify risks and prepare balanced decisions
• Positive attitude and strong interpersonal skills

Responsibilities

• Maintain certification for aseptic gowning and demonstrate the ability to perform all duties using proper aseptic technique.
• Perform equipment preparation, including CIP (Clean-in-Place) and SIP (Steam-in-Place) operations, to prepare equipment for use.
• Execute manufacturing instructions to perform compounding, filtration, formulation, and fill activities for aseptic and terminally sterilized products in accordance with SOPs.
• Strongly adhere to verbal instructions and written procedures when operating production equipment and performing processing steps.
• Accurately complete all required production documentation, ensuring forms, logbooks, form preparations, and batch records are complete, reviewed, and meet Good Documentation Practices (GDP).
• Perform room sanitization activities to maintain controlled environment conditions.
• Identify, escalate, and document events that deviate from normal operations; participate in investigations as needed; assist in introducing new manufacturing schemes into the GMP manufacturing facility.
• Execute routine and critical operations, as well as commissioning and validation activities, as assigned.
• Support the engineering, warehouse, and facilities departments to build cross-functional skills, as required.
• Perform additional duties as assigned.
• Revise and author Standard Operating Procedures (SOPs) and Batch Records.
• Assist with the formulation and validation of new processes in partnership with the tech transfer group.
• Ensure sanitization and sterilization practices are followed, including building, cleaning, sanitizing, and sterilizing equipment and components to support production operations.
• Maintain responsibility for floor inventory and communicate schedule changes to the Supervisor, as needed.
• Assist with training of Manufacturing Associate I’s.

Benefits

• Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
• Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
• 401(k) and 401(k) matching
• PTO, Sick Time, and Paid Holidays
• Education Assistance
• Pet Insurance
• Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more)
• Financial Perks and Discounts

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree