Validation Engineer

Jobgether; United States; Remoto; USD 110.000 - 125.000; Tempo pieno

Vantaggi offerti da questo lavoro

Annual base salary 110k–125k USD

Fully remote options

Career development & learning

Flexible working hours

Global teams

Descrizione del lavoro

Jobgether, on behalf of our partner in the United States, is seeking a Senior Validation Engineer to lead validation activities across equipment, utilities, facilities, and computerized systems within GMP contexts. You will develop strategies, write protocols, review reports, and mentor junior engineers while coordinating with Quality and Maintenance teams.

The role offers fully remote work options with occasional site collaboration; strong knowledge of cGMP, FMEA, and CSV is essential for

Competenze

• Must have a life sciences/engineering background with experience in regulated environments.
• Experience writing and reviewing IQ/OQ/PQ documents and CSV reports.
• Proven ability to lead validation workstreams and mentor junior staff.
• Familiarity with regulatory inspections and audits related to validation.

Mansioni

• Lead validation lifecycle activities for equipment, utilities, and facilities.
• Develop qualification strategies, protocols, and test methods.
• Prepare summary reports for validation, commissioning, and requalification.
• Collaborate across Engineering, Quality, and Maintenance teams.
• Mentor junior validation engineers and coordinate cross-functional activities.
• Address regulatory findings and support inspections as needed.
• Oversee P&ID walkdowns and thermal mapping activities.

Conoscenze

GxP validation

cGMP knowledge

FMEA

Risk-based validation

CSV validation

IQ/OQ/PQ protocols

Documentation

Leadership

Formazione

Bachelor’s degree in Life Sciences or Engineering

Strumenti

CSV software

QA documentation templates

Descrizione del lavoro

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Validation Engineer based in the United States.

As a Senior Validation Engineer, you will lead critical validation activities supporting the development and delivery of life-enhancing therapies within highly regulated pharmaceutical, biotechnology, and medical device environments. You will oversee the validation lifecycle for equipment, utilities, facilities, computerized systems, and manufacturing processes, ensuring technical excellence and compliance with applicable quality standards. Working across complex client and technology-transfer projects, you will develop and execute qualification strategies, manage technical documentation, and help resolve validation challenges. You will also serve as a subject matter expert, partnering with Engineering, Quality, Maintenance, and other teams to keep projects on track. This role offers the opportunity to contribute to meaningful scientific and operational outcomes while mentoring colleagues and supporting continuous improvement.

Accountabilities

• Lead the preparation and execution of validation lifecycle documentation, including FAT, SAT, IQ, OQ, and PQ, for equipment, utilities, facilities, cleaning processes, shipping systems, and other GMP-regulated assets.
• Oversee validation activities for internal and client technology-transfer projects, including authoring, executing, reviewing, and closing risk assessments, validation plans, protocols, test methods, and final reports.
• Write, review, and update qualification and verification documentation, including SOPs, validation master plans, execution plans, user and functional requirements specifications, design specifications, FAT documents, verification protocols, and commissioning procedures.
• Prepare comprehensive summary reports covering validation, verification, commissioning, and requalification activities.
• Develop and support procedures, investigations, protocols, reports, and change controls in collaboration with Maintenance, Engineering, and Quality teams.
• Lead P&ID walkdowns to verify system installation, configuration, and readiness.
• Perform and oversee thermal mapping activities for temperature-controlled chambers, warehouses, and SIP processes.
• Support the investigation and resolution of regulatory observations, audit findings, and manufacturing site issues related to validation.
• Lead periodic reviews and requalification activities for temperature-controlled systems and other validated assets.
• Provide technical guidance and mentorship to junior validation engineers and contribute to team development.
• Coordinate cross-functional validation activities to ensure alignment with project timelines, operational requirements, and quality expectations.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or a related technical discipline.
• 7–11 years of experience in the biotechnology, pharmaceutical, or medical device industry.
• Strong understanding of FDA current Good Manufacturing Practices (cGMP), Failure Mode and Effects Analysis (FMEA), and risk-based validation principles.
• Advanced expertise in equipment validation, computerized systems validation (CSV), analytical methods, and process validation.
• Extensive experience developing protocols for automated production systems, particularly computerized equipment and systems.
• Demonstrated ability to author and review IQ, OQ, PQ, and CSV documentation and reports.
• Experience supporting regulatory inspections, audits, remediation activities, and the resolution of compliance findings.
• Strong written and verbal communication skills, with the ability to explain complex technical topics to diverse stakeholders.
• Excellent organizational, analytical, and documentation skills, with the ability to manage multiple priorities independently.
• Strong problem-solving capabilities, including experience supporting investigations and root-cause analysis.
• Proven ability to lead validation workstreams, collaborate across functions, and mentor junior team members.
• Ability to meet the role’s physical requirements, including regular computer use, walking and sitting, and occasionally lifting or carrying items weighing up to 25 pounds.
• Must be currently authorized to work in the United States, as employment visa sponsorship is not available.

Benefits

• Annual base salary range of $110,000–$125,000, depending on experience, qualifications, geographic location, and other job-related factors.
• Annual incentive plan.
• Comprehensive benefits package.
• Flexible paid time off and company-paid holidays.
• Flexible working hours.
• Fully remote work options for most positions, with the flexibility to work from various locations.
• Office locations available in Greater Boston, San Diego, Boulder, and India.
• Ongoing professional development, career growth, and learning opportunities.
• Employee recognition programs and a culture focused on collaboration, innovation, and individual contributions.

We appreciate your interest and wish you the best!