Manufacturing Associate III

PSC Biotech® Corporation; York (York County); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Medical, Dental, Vision premiums paid

401(k) and matching

PTO, sick time, holidays

Education assistance

Pet Insurance

Fitness benefits and discounts

Job summary

BioTechnique is seeking a seasoned Manufacturing Professional to perform complex aseptic operations under GMP/ISO guidelines. You will handle aseptic and non-aseptic filling, equipment prep, cleaning, dissolution and formulation per SOPs, while maintaining rigorous GDP-compliant documentation.

The role requires a life sciences degree and 5–7 years in aseptic pharma manufacturing, with a focus on sterile injectables, formulation, and packaging.

Qualifications

• Bachelor’s Degree in Life Sciences or Liberal Arts, or equivalent experience.
• 5-7 years of professional manufacturing experience in an aseptic, FDA-regulated pharmaceutical facility.
• 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.
• Proficient in MS Office/Excel and good documentation practices.

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 instructions and written procedures during production.
• Complete production documentation, logbooks, batch records adhering to GDP.
• Perform room sanitization to maintain controlled environments.
• Identify deviations, participate in investigations, and support GMP facility improvements.
• 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 for equipment and components.
• Maintain floor inventory and communicate schedule changes to Supervisor.
• Perform additional duties as assigned.

Skills

GMP/ISO knowledge

Aseptic technique

Documentation practices

Attention to detail

Communication skills

Ability to manage floor activities

Education

Bachelor’s Degree in Life Sciences or Liberal Arts

Tools

MS Office/Excel

Job description

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, elevate, 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.
• 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.
• Perform additional duties as assigned.

Additional Level III Responsibilities

• Lead teams to complete manufacturing activities.
• Initiate deviations or investigations of varying complexity, working with cross-functional departments to identify root cause and implement appropriate corrective actions.
• Assist the Supervisor, Engineer, and/or Facilities team with investigations; communicate quality issues or concerns to the Supervisor and QA; interact with cross-functional support teams such as Quality Assurance, Quality Control, Engineering, R&D, and Validation.
• Assist with training of Manufacturing Associate I’s and II’s.

Requirements

• 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 pharmaceutical 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 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.

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

PSC 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.