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 is a W2 Temp position, with potential FTE transition. Hiring for various shift schedules, part-time or full-time.

We are hiring a motivated Manufacturing Associate to join our team! This role is responsible for performing routine and critical manufacturing operations, including but not limited to executing routine and specialized cleaning activities, work functions in aseptic filling, equipment prep, cleaning dissolution, and formulation activities, while ensuring compliance with current GMP/ISO standards as defined in FDA and EU regulations

Execute manufacturing instructions for equipment preparation, compounding, filtration, formulation, and fill activities for aseptic and terminally sterilized products in accordance with SOPs.

Adhere to verbal instructions and written procedures when operating production equipment and performing processing steps; accurately complete all required production documentation.

Ensure documentation (forms, logbooks, batch records, etc.) are complete, reviewed, and compliant with good documentation practices.

Perform room sanitization activities to maintain controlled environment conditions.

Perform floor-to-ceiling cleaning using approved methods and disinfectants while following precise documentation practices. This includes operating a 3-bucket mop system, mopping ceilings, walls, and floors, wiping all horizontal surfaces, and ensuring all cleaning activities are fully documented per SOPs.

Adhere strictly to USP guidelines and internal SOPs for cleanroom sanitation.

Carry out daily, weekly, and monthly cleaning tasks, including surface cleaning and deep sanitation in cleanrooms.

Wear and manage PPE, such as shoe covers, hair nets, smocks, and full bunny suits, in accordance with cleanroom protocols., and using Sporklenz disinfectant.

Identify, escalate, and document deviations from normal operations; participate in investigations as needed.

Assist in the introduction of manufacturing schemes into the GMP manufacturing facility.

Carry out all routine and critical operations, as well as commissioning and validation activities, as assigned.

Maintain general knowledge of aseptic techniques, retain certification for aseptic gowning, and demonstrate competence in performing duties with proper aseptic technique.

Perform and ensure completion of CIP (Clean-in-Place) and SIP (Steam-in-Place) operations to prepare equipment.

Support cross-functional operations by assisting engineering, warehouse, and facilities departments as required.

Additional responsibilities as assigned. ?

Requirements

Associate or Bachelor's Degree in Life Sciences, Technical Discipline, or Liberal Arts. Or, High School Diploma with a minimum of 1-3 years experience in FDA Regulated, pharmaceutical, and/or cleanroom environments.

Familiarity with formulation, filling, primary packaging, and aseptic processing. Experience with sterile injectable drugs preferred.

Experience in reviewing and creating controlled documents.

Ability to operate a 3-bucket mop system and conduct full-surface cleaning (ceilings, walls, floors, horizontal surfaces).

Comfortable working independently in full PPE and within a temperature-controlled cleanroom environment for extended periods.

Ability to use Sporklenz disinfectant, including wearing a respirator as required.

Must be able to stand, crouch, and clean for extended periods.

Must be able to wear a respirator and bunny suit.

Strong organizational and time management skills.

Self-motivated with the ability to complete multiple-floor activities in an effective and compliant manner.

Flexibility to support varying shift schedules.

Must be authorized to work in the U.S

No C2C at this time.

Benefits

W2 temp roles include our medical and sick time benefits

Equal Opportunity Employment Statement

PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant's, employee's, or intern's actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.

BioTechnique LLC

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