Manufacturing Associate II

PSC Biotech•York, PA

6d•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. The Experience 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. Your Role This position is responsible for performing a variety of complex tasks under general guidance and in accordance with the manufacturing instruction set and current GMP/ISO requirement and standards as defined in FDA and EU applicable Regulations. With general supervision the individual will perform routine and critical manufacturing operations, including but not limited to work functions in aseptic and non-aseptic filling, equipment prep, cleaning dissolution and formulation activities. The individual may provide support in other departments within the company, including but not limited to, engineering, warehouse and facilities. Core 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. Additional Level II Responsibilities: 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.

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.