Validation Engineer, Autoclave

Piper Companies is currently seeking a Validation Engineer (Autoclave Focus) for an opportunity in Hunt Valley, MD to join a local CDMO.

Job Title: Validation Engineer (Autoclave Focus)

Location: Hunt Valley, MD (Onsite)

Employment Type: Full-Time / Contract (Project-Based with Extension Potential)

Position Summary:

We are partnering with a leading pharmaceutical/CDMO organization to support a critical validation initiative following recent regulatory activity. This is a high-visibility, urgent opportunity for a Validation Engineer with strong autoclave experience to make an immediate impact. The role is heavily focused on autoclave qualification and sterilization validation, with opportunities to expand into broader equipment and facility validation efforts as new projects ramp up.

Key Responsibilities:

Execute autoclave qualification and validation activities (IQ/OQ/PQ)
Develop, review, and execute validation protocols and reports
Perform cycle development, thermal mapping, and load studies
Analyze validation data and ensure accurate, compliant documentation
Support facility and equipment qualification efforts beyond autoclaves
Collaborate closely with on-site validation leadership and cross-functional teams
Investigate deviations, implement corrective actions, and support audits/inspections
Maintain compliance with FDA, cGMP, and applicable industry standards

Required Qualifications:

Bachelor’s degree in Engineering, Life Sciences, or related field (or equivalent experience)
2–3+ years of hands-on autoclave validation experience (required)
Proven ability to execute validation work independently and efficiently
Experience in GMP-regulated pharmaceutical or CDMO environments
Strong understanding of validation principles and regulatory expectations
Ability to work onsite and collaborate effectively with cross-functional teams

Preferred Qualifications:

Experience with additional equipment validation (e.g., freezers, sterilization systems)
Engineering background (Chemical Engineering preferred, not required)
Familiarity with sterilization standards (e.g., ISO 17665)
Experience in aseptic or cleanroom environments
Open to diverse technical backgrounds, including military experience

Key Competencies:

Strong execution and problem-solving skills
Ability to “hit the ground running” in a fast-paced environment
Excellent technical writing and data analysis capabilities
High attention to detail and commitment to quality
Effective communication and ability to escalate issues appropriately

Logistics:

Location: Hunt Valley, MD (onsite required)
Candidates: Local preferred; travel candidates considered (PA/NJ/VA region)
Schedule: May require off-shift or weekend work based on project needs
Interview Process: 1–2 virtual interviews with quick turnaround

Why This Role?

Immediate start on a priority, high-visibility project with executive attention
Strong potential for extension as additional validation projects come online
Opportunity to contribute to a growing validation program within a leading organization
Hands-on, impactful role in a fast-moving, collaborative environment

Compensation:

Salary Range: $55-$60 / hour, Commensurate to exp.
Benefits: Medical, Dental, Vision

This job opens for applications on 4/20/2026. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords: CQV, validation, equipment, commissioning, qualification, decommissioning, ECQ, IQOQPQ, IQ, installation qualification, OQ, operational qualification, PQ, performance qualification, process validation, lab, laboratory equipment, HPLC, high performance liquid chromatography, UPLC, ultra performance liquid chromatography, ultra-performance, high-performance, chromatographic system, CSV, computer system validation, FDA, IHC, compliance, regulatory, inspections, reporting, control systems, MES, manufacturing execution systems, GALP, good automated laboratory practices, GLP, good laboratory practices, GMP, good manufacturing practices, QC, quality control, software upgrades, SOPs, standard operating procedures, work instructions, safety protocols, solutions, equipment commission, calibration, repair, maintenance, cGMP, current good manufacturing practice, GXP, SDLC, software development life cycle, 21CFR part 11, GDP, good documentation practice, pharma, pharmaceutical, CMMS, computerized maintenance management system, CMS, calibration management syste

Show more Show less