Sharp Sterile Manufacturing Jobs in Usa

Description

As a Manufacturing Engineering Intern at Elliott Manufacturing, you will have the opportunity to apply learned knowledge and skills while gaining valuable hands-on experience to start your career in Engineering. This internship will provide exposure to a manufacturing plant while also supporting other CentroMotion businesses remotely.

Responsibilities:

1. Establish inventory of manufacturing and quality control tooling.

2. Utilize existing Gage Control software to track tooling (if possible).

3. Establish physical storage locations for all tooling.

4. Implement 6S for tooling, so that missing tooling can be easily physically identified.

5. Establish check-in/check-out process for tooling.

6. Review QC tooling and ensure quantities of tools are appropriate for each tool type (too many/too little).

7. Look for opportunities to reduce QC calibrations for unnecessary and overabundance of tools.

8. Work with operators to create work instructions

Requirements

• Student of Junior or Senior standing currently pursuing a degree in Engineering or related field
• Strong attention to detail and organizational skills
• Excellent communication and interpersonal skills
• Proficient in Microsoft Office Suite
• Ability to multitask and prioritize tasks effectively
• Must be able to maintain confidentiality and sensitive information

Contract role onsite in Phoenix, AZ.

• New 503A sterile compounding facility in start up mode.
• Support Training program:

Personnel will need to be trained in sterile compounding activities:

• Hand hygiene, sterile garbing, gloving
• Materials Transfer
• Kitting
• Cleaning
• Weighing/Mixing
• Sterile compounding/transfer
• Filling/capping

Providing Sterile Compounding Training. Experience in USP compounding is preferred, but experience in aseptic training for 503b or aseptic drug manufacturing could be sufficient.

*Consulting/Contract opportunity lasting 3 weeks with opportunity for extension

Job Title: Sterility Assurance Technician

6 month contract to hire

onsite - Pleasant Prairie, WI

Key Responsibilities:

Participate in qualification and validation activities related to bioburden control strategies for facilities and equipment.

Execute routine sterility assurance activities

Support media fill simulations and provide documentation to ensure compliance with regulatory guidelines.

Analyze and interpret environmental monitoring data, identifying trends and potential risks to product quality.

Collaborate with cross-functional teams to troubleshoot contamination events and recommend corrective actions.

Maintain accurate records and ensure timely reporting of sterility assurance results.

Qualifications:

Experience in qualification or validation activities supporting contamination control measures in manufacturing facilities or equipment.

Comprehensive understanding of aseptic techniques, either through hands-on operational experience or involvement in media fill processes.

Prior experience participating in media fill simulations in a regulated environment.

Ability to work in a fast-paced environment with strong attention to detail and organizational skills.

Excellent written and verbal communication skills.

Bachelor's degree in Microbiology, Biology, or a related field preferred, or equivalent work experience.

Professional Experience

Senior Manufacturing Support Engineer

Pharmaceutical Manufacturing Operations

Billerica, MA

Manufacturing Equipment Support

• Provide advanced troubleshooting and rapid recovery support for pharmaceutical manufacturing equipment to minimize downtime and maintain production schedules.
• Serve as Subject Matter Expert (SME) for critical equipment including isolators, vial filling lines, lyophilizers, sterilizers, washers, and packaging systems.
• Monitor process operations to ensure compliance with manufacturing specifications and cGMP regulations.

Process Equipment Reliability

• Maintain operational readiness of sterile filling and process equipment supporting continuous manufacturing operations.
• Troubleshoot complex issues involving mechanical, electrical, automation, and process systems.
• Operate production equipment for setup, testing, or manufacturing support as required.

Validation & Compliance Support

• Support validation maintenance programs and equipment re-qualification activities.
• Assist Validation Engineers during FAT, SAT, IQ, OQ, and PQ activities for new or modified equipment.
• Maintain equipment documentation and records to support validated manufacturing operations.

Quality & Regulatory Support

• Support change control, deviations, and CAPA investigations within TrackWise or similar systems.
• Ensure compliance with FDA regulations and current Good Manufacturing Practices (cGMP).
• Assist with maintenance SOP improvements and documentation updates.

Engineering & Process Support

• Support Manufacturing Engineers with retrofit, improvement, and upgrade projects for manufacturing and critical systems.
• Provide mentorship and technical support to peers within engineering and maintenance teams.

Operational Support

• Participate in 24/7 on-call support for critical manufacturing equipment.
• Perform non-routine and off-hours troubleshooting activities when required.
• Ensure safe work practices and adherence to company safety policies.

Technical Skills

Systems & Software

• CMMS Systems
• TrackWise
• MasterControl
• LMS
• Building Automation Systems
• Microsoft Office Suite

Technical Skills

• Mechanical Systems
• Electrical Systems
• Automation Systems
• Equipment Maintenance
• Process Equipment Troubleshooting
• Engineering Drawings & Schematics

Education

Bachelor of Science – Mechanical Engineering (Preferred)

or equivalent engineering experience

Associate Degree – STEM Field (Optional)

High School Diploma or Equivalent

Certifications & Training

• cGMP Training
• HAZMAT Training
• State Boiler License (Preferred / Obtain within 6 months)
• Electrician License (Preferred)
• Technical Certifications (Preferred)

Additional Qualifications

• Knowledge of aseptic manufacturing techniques
• Experience in pharmaceutical plant operations and maintenance environments
• Ability to read and create engineering drawings and schematics
• Proficient in hand tools, power equipment, and production machinery
• Valid Driver’s License

Physical & Work Environment

• Ability to lift up to 70 lbs
• Work in manufacturing, laboratory, and warehouse environments
• Exposure to noise, temperature variations, and controlled radiation levels
• Use of PPE including safety shoes, glasses, and gloves

About Made Scientific

Made Scientific is a leading US-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical-and-commercial supply. Made Scientific combines the agility and entrepreneurial spirit of a specialist CDMO with the global expertise and resources of GC Corporation of South Korea, a global leader in the pharmaceutical and biotechnology sectors.

Position Summary

The Manufacturing Associate will support Cell Therapy Operations at our GMP-compliant facility, playing a critical role in the production of cutting-edge cell therapies. This position is ideal for a detail-oriented professional with strong aseptic technique and a proven ability to quickly master complex processes in a cleanroom environment. The successful candidate will demonstrate a deep commitment to current Good Manufacturing Practices (cGMP) and thrive in a collaborative, quality-driven setting. This role requires precision, adaptability, and a strong quality mindset to ensure the consistent delivery of high-standard therapeutic products.

Key Responsibilities

• Perform aseptic manufacturing operations within a classified cleanroom environment, ensuring compliance with all cGMP and safety standards.

• Execute complex procedures for cell therapy manufacturing and sterile product operations—including cell culture, formulation, and cryopreservation—while maintaining strict adherence to written procedures, batch records, and cGMP regulations.

• Operate and maintain specialized manufacturing equipment, ensuring proper calibration and functionality.

• Monitor and document all production processes with precision, ensuring traceability and compliance with regulatory standards.

• Identify and escalate deviations or non-conformances; participate in root cause analyses and implement corrective actions.

• Collaborate cross-functionally with Quality, Process Development, and Engineering teams to support continuous improvement initiatives.

• Perform routine cleanroom maintenance, including environmental monitoring, cleaning, and sterilization activities.

• Maintain an organized, compliant workspace by following 5S principles and minimizing contamination risks.

• Participate in training sessions to stay current with manufacturing techniques, quality standards, and safety protocols.

• Support process development activities during technology transfer.

• Aseptically gown and work in ISO 8, 7, and 5 cleanroom environments and stand for extended periods.

• Assist in creating and reviewing Standard Operating Procedures (SOPs) and Master Batch Records (MBRs).

• Review MBRs daily to ensure documentation is accurate and complete.

• Participate in audits, inspections, qualifications, and validation activities.

• Handle chemicals such as corrosives, solvents, and biohazardous materials safely.

• Perform other duties as assigned.

Required Qualifications

• Bachelor’s degree in Biology, Biotechnology, or a related field preferred; equivalent experience will be considered.

• 1–3 years of experience in GMP manufacturing, preferably in cell therapy, biologics, or pharmaceutical CDMO operations.

• Strong knowledge of aseptic techniques and cleanroom protocols.

• Proficiency in basic mathematical concepts, including scientific notation.

• Proven ability to learn and master complex processes quickly.

• Exceptional attention to detail with a strong commitment to quality standards.

• Excellent collaboration, communication, and interpersonal skills.

• Ability to work effectively in a fast-paced, dynamic environment with shifting priorities.

Preferred Qualifications

• Experience in aseptic cell culture processing in ISO 5 biosafety cabinets, using universal precautions for handling human-derived materials.

• Familiarity with cell therapy automation technologies, closed system culture vessels, cell washers, and cell separation technologies for autologous or allogeneic product manipulation.

• Experience handling, propagating, isolating, activating, and cryopreserving human primary cells, including T cells.

• Proficiency in basic computer applications (e.g., Microsoft Office, electronic batch record systems).

Physical Requirements

• Ability to stand for extended periods and perform repetitive tasks in a cleanroom environment.

• Must be able to lift up to 25 lbs. and work in full cleanroom gowning and PPE for extended durations.

• Ability to perform essential job functions safely and successfully in compliance with ADA, FMLA, and other applicable standards, including meeting productivity expectations.

• Willingness to bend, stoop, carry, reach, climb, or stand on elevated benches or step stools.

• Must be comfortable working with cell-based products, chemicals, and hazardous materials.

Work Schedule

• Must be available for shift work, including off-shift hours, weekends, and holidays, as needed to meet production demands. Flexibility to accommodate changing production schedules is required.

At STERIS, we are dedicated to creating a healthier and safer world through innovative healthcare and life science solutions. As industry experts in sterile processing, our teams process over 150 million instruments annually for our customers. We are looking for a dynamic and experienced Senior Manager, Sterile Processing to join our team and lead our facility's production and quality efforts. As a Senior Manager Sterile Processing, you'll oversee production and quality performance across outsourced facilities and customer accounts. You'll be the driving force behind ensuring customer satisfaction by proactively managing daily operations, meeting contractual obligations, and upholding the highest standards in sterile processing. You'll provide on-site support, training, and strategic communication to both internal teams and client facility staff. You'll ensure strict compliance with regulatory standards from the Department of Health, TJC, DNV, OSHA, CDC, AAMI, and AORN. Leveraging your expertise in process improvement, you'll lead impactful initiatives using STERIS Process Improvement (PI) modules, driving efficiency, safety, and service excellence across all operations.

This is an onsite role based in Chicago, IL.

What you'll do as a Senior Manager Sterile Processing:

Lead and inspire a high-performing leadership team to deliver exceptional day-to-day service that meets customer needs, contractual obligations, and business goals.

Build and maintain strong relationships with customers at all levels, including executive leadership, ensuring satisfaction through regular KPI reviews, pulse checks, and bi-annual business reviews.

Proactively resolve customer issues by identifying root causes, implementing corrective action plans, and tracking measurable outcomes.

Collaborate with STERIS Business Development and internal teams to identify growth opportunities, support contract changes, and expand service offerings.

Ensure full compliance with all regulatory standards (DOH, TJC, DNV, OSHA, CDC, AAMI, AORN) and facility policies across all operations.

Oversee staffing strategies, aligning resources with fluctuating demand and ensuring leadership is equipped to do the same.

Foster a culture of employee engagement, retention, and safety through ongoing communication, training, and development.

Manage recruitment, onboarding, coaching, and performance management to build a skilled and motivated team.

Drive continuous improvement by leading process improvement initiatives using STERIS PI modules and coaching others in PI methodology.

Ensure accurate and timely completion of all administrative functions, including documentation, billing, inventories, and time records.

Effectively manage P&L responsibilities, ensuring financial targets are met while delivering high-quality service.

Implement new policies, procedures, and services in alignment with contracts and STERIS standards to enhance customer experience.

Collaborate across STERIS operations, service, and finance teams to support business objectives, manage invoicing, and ensure accurate financial reporting.

The Experience, Skills, and Abilities Needed:

High School Diploma

10 years of experience in Sterile Processing and 5 years of Sterile Processing leadership

CRCST or CBSPD Certification. If not certified at point of hire, certification must be obtained within 12 months of hire.

Must be able to be compliant with hospital/customer credentialing requirements.

Preferred Experience:

Bachelor's degree

Leadership experience supporting a minimum of 20 Operating Rooms

Pay range for this opportunity is $113,900.00 - $147,400.00. This position is eligible for bonus participation.

Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc.

STERIS offers a comprehensive and competitive benefits portfolio.

STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law.

Company Description

White Label Pharmacy is a growing mail-order and specialty pharmacy focused on delivering high-quality, compliant, and patient-centered pharmaceutical care. We specialize in customized medications and innovative wellness solutions, supporting providers and patients nationwide.

Role Description

We are seeking a Sterile Compounding Pharmacist to oversee and execute sterile compounding operations in accordance with USP and standards. This role is critical in ensuring the safety, accuracy, and compliance of compounded sterile preparations while maintaining operational excellence within our pharmacy.

Qualifications

• Doctor of Pharmacy (PharmD) from an accredited institution
• Active and unrestricted Texas Pharmacist License
• Experience in sterile compounding (preferred but not required)
• Strong understanding of USP and regulations
• High attention to detail and commitment to patient safety
• Ability to work in a fast-paced, team-oriented environment
• Strong communication and organizational skills

Under general supervision, deburr, weld prep and/or clean titanium and aluminum components and sub-assemblies to support all core processes, such as machining, welding, and NDE.

Essential Responsibilities

• 
  
• Support the highest standards of safety and environmental practices.
  
• Deburr machined components for sharp edges.
  
• Hand blend machined and welded surfaces to drawing requirements.
  
• Hand abrade components to desired finish for weld.
  
• Clean components and assemblies per drawing and/or manufacturing work instructions.
  
• Make a continuous effort to improve operations, decrease turnaround times, streamline work processes, and work cooperatively.
  
• Perform other related duties, as assigned, for the purpose of ensuring an efficient and effective work environment.
  
• Check work after completion of each operation in job and/or completed job to ensure it is complete per drawing and/or manufacturing work instruction.
  

$23-$26 per hour

• High school diploma or General Education Degree (GED).
• Aerospace manufacturing experience preferred.

This position is currently accepting applications.

Apply Now

MANUFACTURING PLANT IN WAUKESHA WI IS LOOKING FOR MANUFACTURING ENGINEERS. LOOKING FOR SOMEONE SHARP WITH CONTINUOUS IMPROVEMENT ENGINEER.

SHIFT: 7AM-330PM

SALARY: $73K-$94K + 5% TARGET BONUS

PTO: YOU GET 2 WEEKS AFTER 90 DAYS (5 PERSONAL/SICK DAYS & 5 DAYS PTO)Manufacturing Engineer

Core Responsibilities

• Develop and optimize manufacturing processes, routings, work instructions, and standard work to meet safety, quality, delivery, and cost targets.
• Lead continuous improvement initiatives focused on OEE, scrap reduction, labor efficiency, throughput, and productivity gains.
• Design and implement tooling, fixtures, automation, and poka-yoke solutions to improve process capability and repeatability.
• Analyze production data to identify bottlenecks and downtime drivers; lead structured root-cause analysis (5 Why, Fishbone, A3) and corrective actions.
• Partner with Quality to develop control plans, PFMEAs, Cp/Cpk studies, and standardized inspection methods.
• Support new product introductions through process development, equipment validation, pilot builds, and launch activities.
• Drive cost-reduction initiatives via cycle time improvements, material yield optimization, and value engineering.
• Collaborate with Operations and Maintenance to improve equipment reliability, preventive maintenance strategies, and uptime.
• Maintain accurate manufacturing documentation including BOMs, routings, standard times, work instructions, and process flow diagrams.
• Evaluate capital equipment needs, build ROI justifications, and manage installation and commissioning.
• Provide hands-on floor support to troubleshoot issues and stabilize daily production.
• Ensure compliance with safety, regulatory, and internal operational standards.

Qualifications

Required:

• Bachelor’s degree in Mechanical, Manufacturing, Industrial, or related Engineering discipline
• 3–7 years of Manufacturing Engineering or process improvement experience
• Strong understanding of process flow development and production optimization
• Experience with structured problem-solving methodologies (5 Why, Fishbone, A3, etc.)
• Proven record of improving productivity, quality, or cost in a manufacturing environment

Preferred:

• Experience in job shop or mixed-model manufacturing
• Familiarity with ERP/MES systems (NetSuite, SAP, Oracle, SmartFactory, etc.)
• Automation, robotics, CNC, or assembly experience
• Lean or Six Sigma certification
• Capital equipment implementation and ROI justification experience