Bioprocessing Production Specialist

Accelera; Waunakee (WI); On-site; USD 60,000 - 85,000; Full time

Job summary

Accelera is seeking a Bioprocessing Production Specialist in Wisconsin to execute pilot and commercial-scale manufacturing while upholding cGMP standards and driving process development initiatives.

You will work with cross-functional teams, manage documentation, and ensure regulatory compliance in a clean, safe production environment. This role emphasizes adherence to SOPs, equipment maintenance, and inventory control.

Qualifications

• High School diploma or GED required.
• Experience in a regulated manufacturing or laboratory environment.
• Strong recordkeeping and documentation skills.
• Ability to follow complex technical instructions and safety protocols.

Responsibilities

• Execute complex manufacturing processes for GMP and non-GMP products at scale.
• Maintain precise documentation and SOP compliance for regulatory adherence and product integrity.
• Collaborate with cross-functional teams to execute validation protocols and research studies.
• Support Quality Assurance and Quality Control with accurate data in a compliant environment.
• Manage sanitation and maintenance of production equipment and facilities to ensure readiness.
• Handle chemical agents with strict adherence to safety protocols and PPE usage.
• Proactively manage supply inventory to prevent production delays and maintain a clean, organized workspace.

Skills

Instruction following

Documentation/records

Regulated environment experience

Education

Associate degree in biotech/chemistry

Job description

As a Bioprocessing Production Specialist, you will play a vital role in the lifecycle of pharmaceutical development by executing pilot and commercial-scale manufacturing operations. You will contribute to the advancement of life-saving products by ensuring rigorous adherence to cGMP standards and supporting critical process development initiatives.

About the Role

As a Bioprocessing Production Specialist, you will play a vital role in the lifecycle of pharmaceutical development by executing pilot and commercial-scale manufacturing operations. You will contribute to the advancement of life-saving products by ensuring rigorous adherence to cGMP standards and supporting critical process development initiatives.

Responsibilities

• Execute complex manufacturing processes for both GMP and non-GMP products, ensuring high-quality output at scale.
• Maintain precise documentation and strictly follow Standard Operating Procedures (SOPs) to ensure regulatory compliance and product integrity.
• Collaborate with cross-functional teams to execute validation protocols, research studies, and laboratory experiments that drive process innovation.
• Support Quality Assurance and Quality Control departments by providing accurate data and maintaining a compliant production environment.
• Manage the sanitation and maintenance of specialized production equipment and laboratory facilities to ensure operational readiness.
• Handle chemical agents, including acids and solvents, while strictly adhering to safety protocols and utilizing appropriate Personal Protective Equipment (PPE).
• Proactively manage supply inventory to prevent production delays and maintain an organized, sanitary workspace.

Qualifications

Required Skills

• High School diploma or G.E.D. equivalent.
• Demonstrated ability to follow complex technical instructions and safety procedures.
• Experience working in a regulated manufacturing or laboratory environment.
• Proficiency in maintaining accurate records and documentation.

Preferred Skills

• Associate degree or higher in Biotechnology, Chemistry, or a related scientific discipline.
• 2+ years of hands-on experience in a biopharmaceutical or chemical manufacturing setting.
• Direct experience with cGMP environments and validation protocols.
• Strong problem-solving skills with the ability to adapt to evolving process requirements.