Top 239 Technical lead Jobs in Quakertown, Pa

Sterility Assurance Lead
Particle Sciences Inc, an Agno Pharma Company —Bethlehem, PA
- Full-time
- Background check
- 5 years
- Bachelor's degree
- Health insurance
- Paid time off
Quick Apply
Metal Fabrication/Laser Operator/2nd Shift Lead
AR Metalcrafters —Souderton, PA
- $28 - $30 an hour
- Full-time
- Mid-level
- Continuous improvement
- In-person
- Health insurance
- Dental insurance
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6d
Industry Standards & Regulatory Affairs Lead
Lutron Electronics Co., Inc —Coopersburg, PA
- Full-time
- 8 years
- Bachelor's degree
- Product management
Building Automation Lead Solutions Architect
H.T. Lyons —Allentown, PA
- Full-time
- System design
- Continuous improvement
- Mentoring
- Health insurance
- Dental insurance
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17h
Lead Installer
Rapid Air HVAC —Pottstown, PA
- $46 - $52 an hour
- Full-time
- Clean driving record
- Management
- Construction site
- 401(k)
- Paid time off
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Lead Substation Protection and Controls Engineer
Leidos —Allentown, PA
- $107,900 - $195,050 a year
- Full-time
- Hybrid work
- Office
- Master's degree
- Continuous improvement
Business Enablement Lead
Lutron Electronics Co., Inc —Coopersburg, PA
- Full-time
- Marketing
- Office
- 3 years
MAINTENANCE TECHNICIAN LEAD
Merlin Entertainments —Plymouth Meeting, PA
- $25 an hour
- Weekends as needed
- Background check
- Mechanic experience
- Military
- Health insurance
- Dental insurance
Vaccines Safety Sciences Lead
CSL —King of Prussia, PA
- Full-time
- Office
- 3 years
- Bachelor's degree
Lead Audio Engineer
New Ridge Fellowship —Gilbertsville, PA
- Part-time
- Background check
- Mid-level
- In-person
- Professional development assistance
- Flexible schedule
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7d
Lead Electrician
Thomas Edison Electric Inc. —Allentown, PA
- Up to $130,000 a year
- 8 hour shift
- Background check
- Clean driving record
- Pass drug screening
- Health insurance
- 401(k)
Quick Apply
Lead Data Engineer
Lutron Electronics Co., Inc —Coopersburg, PA
- Full-time
- Computer Science
- Master's degree
- 8 years
Delivery Assurance - Intermediate / Senior / Lead
PPL Services Corporation —Allentown, PA
- Part-time
- Hybrid work
- Microsoft PowerPoint
- Microsoft Excel
- Office
Quality Assurance Lead - (CMM, PC-DMIS, GD&T)
Harold Beck & Sons Inc. —Newtown, PA
- From $83,000 a year
- Full-time
- Management
- Ability to walk for extended periods
- Mid-level
- Health savings account
- Health insurance
Quick Apply
10d
Developer Team Lead
PPL Services Corporation —Allentown, PA
- Part-time
- Hybrid work
- 7 years
- Research
- Office
Lead Electrical Engineer – Test & Automation
Lutron Electronics Co., Inc —Coopersburg, PA
- Full-time
- Master's degree
- 8 years
- Supervising experience
Senior Developer / Lead Developer
PPL Services Corporation —Allentown, PA
- Part-time
- Hybrid work
- 5 years
- Research
- Office
Director, Portfolio Development Process & Standards Lead
CSL —King of Prussia, PA
- $230,000 - $270,000 a year
- Full-time
- Hybrid work
- Nursing
- Office
- 3 years
Lead Plant Maintenance Technician
Republic Services —King of Prussia, PA
- Full-time
- Mid-level
- 3 years
- Driver's License
- AD&D insurance
- Employee stock purchase plan
Quick Apply
Lead Mechanic - 2nd Shift! Earn up to 100K Annually!
J.P. Mascaro & Sons —Souderton, PA
- Up to $100,000 a year
- Full-time
- CDL B
- ASE Certification
- 5 years
- Paid training
- Health savings account
Quick Apply

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technical lead jobs near quakertown, pa

Sterility Assurance Lead

Particle Sciences Inc, an Agno Pharma Company
Bethlehem, PA

Quick Apply

Job Details

Full-time

Benefits

Health insurance
Paid time off
401(k) matching
Life insurance

Qualifications

Bachelor's degree

Full Job Description

Agno Pharma is and end-to-end CDMO.

Position Summary

The Sterility Assurance Lead serves as the site Subject Matter Expert (SME) for sterility assurance, providing technical leadership for contamination control, aseptic processing, and microbiological quality systems. This position is responsible for ensuring compliance with cGMP requirements and supporting the continuous improvement of sterility assurance programs across sterile manufacturing operations.

Essential Responsibilities

Serve as the site Subject Matter Expert (SME) for sterility assurance, contamination control, and aseptic processing.
Develop, implement, maintain, and continuously improve the site's Sterility Assurance Program and Contamination Control Strategy (CCS).
Provide technical guidance and microbiological oversight for aseptic manufacturing operations, including review of procedures, protocols, investigations, and process improvements.
Perform microbiological risk assessments and evaluate process, equipment, facility, and procedural changes for potential contamination risks.
Develop, maintain, and support the site's media fill (aseptic process simulation) program, including procedures, execution, trending, and investigations.
Develop and maintain aseptic technique training, aseptic behavior training, and personnel gowning qualification programs.
Provide technical oversight of the Environmental Monitoring Program, including trending, investigations, alert/action level assessments, and continuous improvement.
Lead or support microbiological investigations involving environmental monitoring excursions, utility systems, contamination events, media fill failures, sterility assurance deviations, and product bioburden excursions.
Provide technical support for microbiological testing programs, including environmental monitoring, sterility, bioburden, endotoxin, growth promotion, utility monitoring, and microbial identification.
Support implementation of new microbiological testing capabilities, methods, laboratory investigations, and troubleshooting activities.
Provide microbiological expertise during facility, utility, equipment, and process qualification and validation activities related to sterile manufacturing.
Participate in change controls, deviations, CAPAs, quality risk assessments, and continuous improvement initiatives.
Support regulatory inspections and client audits related to sterility assurance.
Collaborate with cross-functional departments to promote contamination control, regulatory compliance, and continuous improvement throughout sterile manufacturing operations.

Qualifications

Bachelor's degree in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, Biomedical Sciences, Biotechnology, or another related scientific discipline.
Minimum of five (5) years of experience in sterility assurance, microbiology, aseptic processing, or sterile pharmaceutical manufacturing within a GMP-regulated environment (seven (7) or more years preferred).
Experience supporting sterile pharmaceutical manufacturing operations, preferably within a sterile injectable pharmaceutical manufacturer or CDMO.
Working knowledge of contamination control strategies, environmental monitoring, media fill programs, aseptic processing, microbiological investigations, and Quality Risk Management (QRM).
Working knowledge of applicable cGMP regulations, GxP principles, and industry standards, including FDA, EU GMP (Annex 1), ICH, USP, ISO, PDA, and WHO guidance applicable to sterile pharmaceutical manufacturing.
Experience supporting microbiology laboratory development or implementation of microbiological testing programs is preferred.
Experience supporting FDA, international regulatory authority, and client inspections is preferred.
Strong technical writing, communication, analytical, and problem-solving skills.
Professional certifications related to microbiology, quality, or sterile manufacturing are desirable

Agno Pharma is an Equal Opportunity Employer

Benefits:

401(k) matching
Health insurance
Life insurance
Paid time off

Work Location: In person

Quick Apply

Refine Your Search

technical lead jobs in quakertown, pa

Sterility Assurance Lead

Metal Fabrication/Laser Operator/2nd Shift Lead

Industry Standards & Regulatory Affairs Lead

Building Automation Lead Solutions Architect

Lead Installer

Lead Substation Protection and Controls Engineer

Business Enablement Lead

MAINTENANCE TECHNICIAN LEAD

Vaccines Safety Sciences Lead

Lead Audio Engineer

Lead Electrician

Lead Data Engineer

Delivery Assurance - Intermediate / Senior / Lead

Quality Assurance Lead - (CMM, PC-DMIS, GD&T)

Developer Team Lead

Lead Electrical Engineer – Test & Automation

Senior Developer / Lead Developer

Director, Portfolio Development Process & Standards Lead

Lead Plant Maintenance Technician

Lead Mechanic - 2nd Shift! Earn up to 100K Annually!

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