Validation Engineer

Location: East Troy

Job Title:

Validation Engineer

Job Description

The Validation Engineer will lead and execute equipment qualification, process validation, cleaning validation, and OCMC procedure development to support a CGMP validation program. This role requires end-to-end ownership of validation deliverables across a range of pharmaceutical manufacturing systems, ensuring full lifecycle traceability and alignment with regulatory expectations.

Responsibilities

+ Execute installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) for pharmaceutical manufacturing equipment, including tablet machines, ampule fillers, tube fill and sealers, herb dryers, and incubators.

+ Author clear, comprehensive validation protocols and reports that meet CGMP and regulatory requirements.

+ Ensure full lifecycle traceability from user requirements specifications (URS) through IQ/OQ/PQ execution to final validation reporting.

+ Contribute to the development and execution of the Validation Master Plan for manufacturing systems.

+ Develop robust cleaning validation strategies and protocols for product-contacting equipment, including acceptance criteria and sampling plans.

+ Coordinate cleaning validation samples with contract testing laboratories and ensure timely, accurate testing and documentation.

+ Design and implement OCMC (Operation, Cleaning, Maintenance, and Calibration) procedures that support and maintain the validated state of equipment.

+ Establish acceptance limits and design swab sampling, rinse sampling, and residue recovery studies to verify cleaning effectiveness.

+ Collaborate closely with Operations, Quality, and Leadership teams to align validation activities with business and production needs.

+ Explain regulatory and validation requirements in practical, business-focused terms to non-quality personnel and support their understanding of compliance obligations.

+ Influence stakeholders without direct authority to build consensus on validation strategies, procedures, and documentation requirements.

+ Support change implementation in environments with developing quality systems, maintaining patience and adaptability while driving compliance.

Essential Skills

+ 4-8+ years of experience in pharmaceutical equipment validation.

+ Demonstrated experience developing and executing IQ, OQ, and PQ protocols for pharmaceutical manufacturing equipment.

+ Strong expertise in equipment qualification, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).

+ Proven experience leading cleaning validation projects from protocol development through report approval.

+ Experience establishing acceptance limits, swab sampling, rinse sampling, and residue recovery studies for cleaning validation.

+ Hands-on experience with process validation in a CGMP environment.

+ Experience qualifying filling, packaging, processing, or production equipment, including liquid, ampule, and tube filling systems.

+ Experience developing Operation, Cleaning, Maintenance, and Calibration (OCMC) procedures to maintain the validated state of equipment.

+ Bachelor's degree in Engineering, Life Sciences, or a related field.

+ Strong understanding of CGMP principles and validation testing methodologies.

+ Ability to explain regulatory and validation requirements in practical, business-oriented language to non-quality stakeholders.

+ Ability to balance compliance objectives with operational realities while maintaining regulatory expectations.

Additional

Skills & Qualifications

+ Experience working in organizations with low process maturity or developing quality systems, with the ability to help shape and strengthen validation practices.

+ Comfort influencing stakeholders without direct authority and building consensus across Operations, Quality, and Leadership teams.

+ Patient, adaptable approach to implementing new procedures and documentation requirements in environments that may be resistant to change.

+ Strong communication and interpersonal skills to collaborate effectively with cross-functional teams.

+ Ability to prioritize and manage multiple validation activities while maintaining accuracy and compliance.

+ Demonstrated capability to contribute to and execute a Validation Master Plan.

+ Attention to detail in authoring validation protocols, reports, and OCMC procedures.

Work Environment

The role operates within a CGMP pharmaceutical manufacturing environment that includes equipment such as tablet machines, ampule fillers, tube fill and sealers, herb dryers, and incubators. The Validation Engineer works closely with Operations, Quality, and Leadership teams and collaborates with external contract testing laboratories for sample analysis. The position involves both documentation-focused work and hands-on activities on the production floor, following appropriate safety and compliance procedures.

The environment emphasizes regulatory compliance, continuous improvement of validation and quality systems, and…