New · posted Nov 11
Tolmar · Pharmaceuticals
Validation Engineer I
- Windsor, CO
- On-site
- Full-time
- Associate & Specialist
The role
Purpose and Scope
The Validation Engineer I is responsible for supporting the planning, execution, and documentation of validation activities in a sterile injectable manufacturing environment. Responsibilities include equipment, facilities, utilities, cleaning and process validation in compliance with cGMP, FDA, EU, and other regulatory requirements.
This position is expected to operate within the framework of Tolmar’s Core Values:
What you need
- Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
- Some experience in validation, preferably in a sterile pharmaceutical or biotech environment.
- Understanding of GMP, FDA and EU regulatory requirements a plus.
- Experience qualifying CTUs and using Ellab temperature mapping systems a plus.
Knowledge, Skills & Abilities
- Proficient in Microsoft Office Suite.
- Knowledge of GMP regulations and validation guidelines.
- Strong technical writing and documentation skills.
- Excellent oral and written communication skills.
- Effective organizational and project management skills.
- Effective troubleshooting and problem-solving skills.
- Ability to maintain gowning requirements for controlled areas.
- Ability to manage multiple projects simultaneously.
- Ability to work both independently and as part of a team.
- Ability to develop and implement creative solutions to problems.
Skills named in this posting
What you'll do
- Assist in the development and execution of validation protocols (IQ/OQ/PQ) for equipment, facilities, utilities (e.g., CTUs, WFI, HVAC), and processes.
- Support cleaning and sterilization validation activities, including autoclaves, SIP systems, and aseptic processes.
- Participate in risk assessments (e.g., FMEA) and support change control evaluations.
- Collect and analyze validation data, prepare summary reports, and ensure documentation is accurate and audit-ready.
- Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, Engineering, and Quality Control.
- Maintain validation lifecycle documentation in accordance with internal procedures and regulatory expectations.
- Support investigations and CAPAs related to validation deviations or failures.
- Stay current with industry trends, regulatory updates, and best practices in validation and sterility assurance.
- Participate in required annual hazardous waste training. Hazardous waste involvement may include, but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical Spill Procedures.
- Perform other related duties as assigned.
Pay
$73,000 – $83,000 a year
Employer provided- Pay: $73,000 - $83,000 annually
- Benefits summary: https://www.tolmar.com/careers/employee-benefits
Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.
Where you'll work
Windsor, COOn-siteOpen in Maps (opens in a new tab)
More jobs in Windsor, COWorking conditions
- Working conditions include general office environment , laboratory and manufacturing settings (clean rooms where gowning is required)
- Business demands may require working extended hours.
From the posting
About Tolmar
Core Values
- Center on People:We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.
- Are Proactive & Agile:We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
- Act Ethically:We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
- Constantly Improve:We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.
- Are Accountable:We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.
Job intelligence
The context around this role
Live data · November 11, 2026
Salary intelligence
How the pay compares
This role's midpoint is 1% below the US median for Validation & CQV roles at this level.
This roleEmployer provided
Associate & Specialist roles in the US20 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $73,000 | — | $83,000 |
| All US (middle half) | $69,375 | $78,500 | $91,500 |
This role: Tolmar's own published range. Comparisons: the base pay employers published on open Validation & CQV roles at the same level on Regulatory Jobs, November 11, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Validation & CQV
The general path across 97 open Validation & CQV roles on Regulatory Jobs, with the titles they carry most. Not Tolmar's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 26 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Validation and qualification9
- GMP and compliance5
- Documentation and SOPs5
- Collaboration and leadership4
- Investigations and CAPA1
- Quality systems and risk1
- Data and digital systems1
- Clinical trial conduct1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Validation & CQV work in pharmaceuticals, led by the two this posting names, each linked to the agency or standards body that publishes it.
- FDAFDA process validation guidance(official source, opens in a new tab)Process Validation: General Principles and PracticesNamed in the posting
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
- ASTMASTM E2500(official source, opens in a new tab)Specification, design and verification of pharmaceutical manufacturing systems and equipment
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- ICHICH Q2(R2) and Q14(official source, opens in a new tab)Validation and development of analytical procedures
- FDAFDA analytical procedures guidance(official source, opens in a new tab)Analytical Procedures and Methods Validation for Drugs and Biologics
- ICHICH Q8(R2)(official source, opens in a new tab)Pharmaceutical development and quality by design
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- USPUSP–NF(official source, opens in a new tab)US Pharmacopeia general chapters and monographs, such as <61> bioburden, <85> endotoxin, <1225> validation
Company hiring pulse
Tolmar on Regulatory Jobs
- 11
- Open roles
- 11
- Distinct roles
- 2
- Locations
By discipline
- Quality10 91%
- Regulatory1 9%
By level
- Senior & Principal5 45%
- Associate & Specialist5 45%
- Manager1 9%
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Validation Engineer I at Tolmar
Open until filled. $73K–$83K a year, employer provided.