Manufacturing Associate I

PSC Biotech • York, PA

8d • 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

• High School Diploma with 1-3 years of work experience in mechanically based or similar role
• 1 year of professional experience in an FDA Regulated Pharmaceutical facility preferred
• Associates Degree in Life Sciences/Liberal Arts field preferred.
• Willingness to work extended shifts and a variable schedule when required
• Flexible individual with good written and verbal communication skills
• MS Office/Excel tools experience
• Excellent communication and organizational skills
• Self-motivated individual with the ability to complete multiple floor activities in an effective and compliant manner.
• Attention to detail with strong mechanical aptitude
• Positive attitude and strong interpersonal skills
• Read, write, and verbally communicate in English
• Strong ability to plan and prioritize complex activities
• Strong analytical skills to identify risks and prepare balanced decisions
• Experience in reviewing and creating controlled documents preferred
• Experience with sterile injectable drugs preferred
• Familiarity with formulation, filling, primary packaging, and aseptic processing preferred
• Strong knowledge of aseptic techniques preferred

Responsibilities

• Execute manufacturing instructions to perform equipment preparation, compounding, filtration, formulation, and fill activities for aseptic and terminally sterilized products in accordance with SOPs
• Strong adherence to verbal instructions and written procedures in operating production equipment and performing processing steps; accurately completes all appropriate production documentation.
• Identifies, escalates, and documents events that deviate from normal operation; participate as needed in investigations. Assist in the introduction of manufacturing schemes into the GMP manufacturing facility
• Execution of all routine and critical operations as well as commissioning and validation activities, as assigned.
• Ensure documentation is complete, reviewed and meets good documentation practices (forms, logbooks, form preps, batch records, etc.).
• Perform room sanitization activities to maintain controlled environment conditions.
• Ensure general knowledge of aseptic techniques and maintain certification for aseptic gowning and demonstrate the ability to perform duties utilizing proper aseptic technique.
• Perform and ensure CIP and SIP operations are performed to prepare equipment.
• Support engineering, warehouse and facilities departments to gain cross-functional skills, as required.
• Additional duties as required.

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: Entry Level
• Education Level: High school or GED