Laboratory Equipment & Validation Specialist

Pharmgate Inc; Omaha (NE); On-site; USD 75,000 - 110,000; Full time

Job summary

Pharmgate Inc in Omaha, NE seeks Laboratory Equipment Specialist to maintain and optimize complex instrumentation, ensuring compliant analytical operations and timely calibrations.

You will collaborate with service engineers and QC teams, perform calibrations, maintenance, validations, and SOP adherence. Bachelor's in science and 3-5 years in FDA-regulated labs required.

This exempt, full-time role offers dedicated team and opportunity to move external support in-house.

Qualifications

• Bachelor of Science in Chemistry, Microbiology, Biology or related field.
• 3-5 years of experience in an FDA regulated pharmaceutical laboratory facility or other highly regulated industry.
• Proficient with high-level lab equipment and SOPs/GMPs.

Responsibilities

• Maintain, perform, review and schedule calibrations for laboratory equipment.
• Develop and perform instrument maintenance, qualification and calibration procedures for existing and new equipment.
• Communicate with service engineers and outside contractors for maintenance and calibrations.
• Work with laboratory management regarding instrumentation and service needs.
• Document analytical activities, calibrations and repairs accurately and timely.
• Support quality control and inspection activities related to instrumentation and metrology.
• Execute method validations as needed.
• Perform peer review of test methods as needed.
• Execute written protocols for method development and R&D as needed.
• Serve as backup to the Senior Scientist and Laboratory Manager as needed.
• Perform other duties as assigned.

Skills

Excellent organizational skills

Advanced knowledge of high-level lab設備

SOPs and GMP compliance

Time management

Verbal and written communication

Reading/understanding English docs

FDA & cGMP compliance understanding

MS Office & SAP B1

Education

Bachelor of Science in Chemistry, Microbiology, Biology or related field

Tools

HPLCs

SAP Business One

Microsoft Office

Job description

Reports To: Laboratory Manager

Department: Laboratory

Classification: Exempt, Full Time

JOB SUMMARY:

The Laboratory Equipment Specialist will maintain and optimize complex laboratory instrumentation to support accurate, efficient and compliant analytical operations. The equipment specialist will work closely with peers to serve as a primary instrumentation technical support person and help assure that instrumentation PMs and calibration are completed on time and within compliance. The Specialist will focus on calibration, repair, qualification review, and troubleshooting of higher-level lab equipment while closely collaborating with service engineers and quality laboratory teams. The Laboratory Equipment Specialist will play a key role in supporting Laboratory management while independently applying advanced scientific knowledge to instrumentation while following SOPs, GMPs and other industry and company required regulations. The Specialist will evaluate, recommend and work to move external support functions to in-house work where feasible.

Requirements

TECHNICAL WORKFLOW RESPONSIBILITIES:

• 1. Provide guidance on instrumentation troubleshooting and repairs for daily efficiency in the laboratory.
• 2. Provide opportunities for on-the-job training and SOP review as necessary.
• 3. Collaborate with the Laboratory Senior Scientist to teach and convey technical knowledge and assist in developing training materials for others to use.

INDIVIDUAL WORKFLOW DUTIES/RESPONSIBILIITIES:

• 1. Maintain, perform, review and schedule calibrations for laboratory equipment.
• 2. Develop and perform instrument maintenance, qualification and calibration procedures for existing and new equipment.
• 3. Communicate directly with service engineers and outside contractors to perform maintenance and calibrations.
• 4. Work with laboratory management regarding impacted instrumentation and service needs.
• 5. Document analytical activities, calibrations and repairs accurately and in a timely manner.
• 6. Support quality control and inspection activities related to analytical instrumentation and metrology.
• 7. Execute method validations as needed.
• 8. Perform peer review of test methods as needed.
• 9. Execute written protocols for method development and R&D as needed.
• 10. Serve as backup to the Senior Scientist and Laboratory Manager as needed.
• 11. Perform other duties as assigned.

REQUIRED SKILLS/ABILITIES:

• 1. Excellent organizational skills and attention to detail.
• 2. Advanced knowledge of high-level laboratory equipment such as HPLCs.
• 3. Ability to follow Standard Operating Procedures (SOPs) and GMP guidelines.
• 4. Excellent time management skills with a proven ability to meet deadlines.
• 5. Strong verbal and written communication skills and the ability to work with all levels of personnel.
• 6. Strong analytical and problem-solving skills including the ability to read and understand instructions and materials in English; add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
• 7. Ability to function well in a high-paced and at times stressful environment.
• 8. Thorough understanding of FDA and cGMP compliance regulations.
• 9. Proficient with Microsoft Office Suite, virtual meeting applications, SAP Business One, and other related software.

EDUCATION AND EXPERIENCE:

• 1. Bachelor of Science in Chemistry, Microbiology, Biology or related field.
• 2. 3-5 years of experience in an FDA regulated pharmaceutical laboratory facility or other highly regulated industry.

PHYSICAL REQUIREMENTS:

• 1. Prolonged periods of standing and walking.
• 2. Exposure to various chemicals and compounds.
• 3. Prolonged periods of sitting at a desk working on computers.
• 4. Ability to occasionally lift 40 lbs. from floor to waist level.
• 5. Ability to occasionally climb stairs.