Job Description

Job Description

Job Description

Job Title: Chemistry Lab Validation Specialist

Job Description

This role focuses on supporting cleaning validation and analytical testing within a regulated chemistry laboratory. The position involves performing swab, rinse, and equipment sampling from manufacturing areas, executing analytical methods, and ensuring that cleaning procedures effectively remove product residues and contaminants. The Chemistry Lab Validation Specialist contributes to method validation and transfer activities, maintains accurate documentation in compliance with GLP and cGMP standards, and collaborates closely with cross-functional teams to support manufacturing and validation projects.

Responsibilities

• Collect swab, rinse, and equipment samples from manufacturing areas in accordance with approved cleaning validation protocols.
• Perform analytical testing using HPLC, UV/Vis, TOC, Atomic Absorption (AA/AAS), and other laboratory techniques to assess cleanliness and verify removal of product residues and contaminants.
• Compile, analyze, and interpret laboratory data to evaluate the effectiveness of cleaning procedures and support validation conclusions.
• Prepare, review, and maintain laboratory documentation, including test records, logs, and reports, in strict compliance with GLP and cGMP requirements.
• Assist in the development, execution, and reporting of cleaning validation studies, ensuring protocols and reports are scientifically sound and compliant with regulatory expectations.
• Support analytical method validation and method transfer activities by performing experiments, documenting results, and contributing to technical reports.
• Maintain compliance with FDA, EU, and internal quality standards, standard operating procedures (SOPs), and applicable regulatory requirements.
• Investigate out-of-specification (OOS) or atypical laboratory results, perform root cause analysis, and support the implementation of corrective actions.
• Update SOPs, databases, validation protocols, and technical reports related to cleaning and analytical validation activities.
• Collaborate with Quality Assurance, Manufacturing, Engineering, and Validation teams to support production schedules, resolve issues, and advance validation projects.
• Participate in internal and external audits and provide accurate, well-organized documentation to support regulatory inspections.
• Ensure laboratory equipment is calibrated, maintained, and operating properly, and promptly report or address any issues impacting data integrity or test performance.

Essential Skills

• Bachelors degree in Chemistry, Biochemistry, Biology, or a related scientific field.
• Minimum of 2+ years of experience in chemistry testing or a similar analytical laboratory role.
• Hands-on experience with analytical chemistry techniques and instrumentation, including HPLC, TOC, UV/Vis, and AA/AAS.
• Strong understanding of cGMP and GLP principles and their application in a laboratory setting.
• Knowledge of FDA and pharmaceutical manufacturing requirements and quality standards.
• Proficiency in laboratory data analysis, including evaluation of test results and trending.
• Strong technical writing skills for preparing protocols, reports, and laboratory documentation.
• High attention to detail and accuracy in documentation and data recording.
• Ability to work independently to manage day-to-day testing activities and meet deadlines.
• Ability to work effectively in a team environment and collaborate with cross-functional partners.

Additional Skills & Qualifications

• Experience in wet chemistry techniques and general laboratory operations.
• Experience in analytical chemistry, including method development or optimization, is beneficial.
• Familiarity with updating and maintaining SOPs, technical reports, and validation documentation.
• Comfort working with laboratory databases and electronic documentation systems.
• Strong organizational skills with the ability to manage multiple priorities and projects simultaneously.
• Effective communication skills to clearly present data, findings, and recommendations to technical and non-technical stakeholders.
• Problem-solving mindset with the ability to support investigations and corrective actions for OOS or atypical results.

Work Environment

The role is based in a regulated chemistry laboratory supporting pharmaceutical manufacturing and validation activities. You will work with advanced analytical instrumentation such as HPLC, UV/Vis spectrophotometers, TOC analyzers, and Atomic Absorption (AA/AAS) equipment, following GLP, cGMP, FDA, and EU quality and regulatory standards. The environment is detail-oriented and documentation-driven, with a strong emphasis on data integrity, safety, and compliance. Work typically involves standard laboratory hours, with occasional flexibility to support production schedules, validation studies, and audits. You will collaborate closely with Quality Assurance, Manufacturing, Engineering, and Validation teams in a professional setting that values teamwork, clear communication, and continuous improvement in laboratory and manufacturing practices.

This is a Contract position based out of Lincoln, NE.

The pay range for this position is $30.00 - $30.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

This is a Contract position based out of Lincoln, NE.

This position is anticipated to close on Oct 21, 2026.

This is a fully onsite position in Lincoln,NE.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.

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