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Full-time
bachelor degree, postgraduate degree
Competitive Compensation, Exposure To International Pharmaceutical Operations, Flexible Work Arrangements, Travel Support, Professional Growth Opportunities
Posted 1h ago
~40 hrs/week
Responsibilities
Lead and execute validation activities for sterile injectable pharmaceutical operations, including equipment, utilities, and HVAC systems. Ensure global regulatory compliance while providing strategic technical leadership and mentoring to client teams.
Requirements
Requires a degree in Pharmacy, Biotechnology, or Engineering with at least 8 years of experience in pharmaceutical validation for sterile products. Must be fluent in English and Spanish and possess deep knowledge of GMP and Annex 1 guidelines.
Full job description
PharmEng / Efor is a leading pharmaceutical and biopharmaceutical consulting company committed to providing innovative solutions to the challenges facing our industries. We pride ourselves on our dedication to quality, safety, and excellence in everything we do. As we continue to grow, we are looking for a highly qualified and motivated Senior CQV Consultant to join our team.
Position Title: CQV Expert
Location: Madrid
Type of Contract: Full-Time / On site
Position Summary:
The Senior Consultant in Qualifications & Validations is responsible for leading and executing validation activities across sterile injectable pharmaceutical operations. This includes equipment, utilities, facilities, and process qualifications, with a strong focus on environmental monitoring and HVAC systems. The role supports multiple sites and projects, ensuring compliance with GMP and global regulatory standards, while providing strategic guidance and technical leadership.
Key Responsibilities:
Lead qualification protocols (URS, DQ, IQ, OQ, PQ) for sterile manufacturing equipment, cleanrooms, HVAC systems, autoclaves, and utilities.
Develop and review validation master plans, risk assessments, and lifecycle documentation for injectable processes.
Oversee process validation, cleaning validation, and sterilization validation in aseptic environments.
Design and implement environmental monitoring programs, including viable and non-viable particle control, alert/action levels, and trending.
Qualify HVAC systems including airflow visualization, pressure differentials, filter integrity testing, and temperature/humidity mapping.
Ensure compliance with global regulatory requirements (FDA, EMA, WHO, PIC/S) and Annex 1 guidelines.
Collaborate with cross-functional teams (Engineering, QA, QC, Manufacturing, Regulatory Affairs) to align validation strategies.
Support audits and inspections by providing validation documentation and expert responses.
Manage and resolve deviations, CAPAs, and Change Controls related to qualification and validation activities.
Provide technical training and mentoring to client teams on validation and environmental control best practices.
Prepare detailed reports and executive summaries for internal and external stakeholders.
Travel to client sites for project execution, troubleshooting, and validation support.
Qualifications:
Bachelors or masters degree in Pharmacy, Biotechnology, Engineering, or related scientific discipline.
Minimum 8 years of experience in pharmaceutical validation, with a strong focus on sterile injectable products.
Deep understanding of aseptic processing, cleanroom classification, HVAC qualification, and contamination control.
Proven experience in environmental monitoring program design and execution.
Strong knowledge of GMP, Annex 1, ICH Q8-Q10, and validation lifecycle principles.
Hands-on experience with CAPA management and Change Control systems.
Demonstrated ability to lead cross-functional teams and mentor junior staff.
Excellent communication and documentation skills.
Fluent in Spanish and English (advanced or native level required).
Willingness to travel.
Preferred Experience:
Experience with injectables.
Strong understanding of aseptic processing, terminal sterilization, and cleanroom operations.
Proven track record managing injectable products, and QA-related activities.
Hands-on experience with CAPA systems, Change Control management, and quality documentation workflows.
What We Offer:
Competitive compensation based on experience and project scope
Exposure to international pharmaceutical operations and regulatory environments
Opportunity to lead high-impact injectable validation programs
Flexible work arrangements and travel support
Collaborative and technically driven work culture
Join us: If you are a dedicated and highly motivated individual with a passion for ensuring the highest standards of Engineering and Quality in the Pharmaceutical Industry, we encourage you to apply. PharmEng / Efor offers a dynamic and inclusive work environment, competitive compensation, and opportunities for professional growth. Be part of our team and contribute to the success of our industry-leading solutions.
PharmEng / Efor is an equal opportunity employer and welcomes applicants from all backgrounds.
Thank you for your consideration and application! We review all resumes and submissions, however, due to the high volume of applications we receive, only approved candidates will be contacted.
Now part of the Efor Group | Committed To Excellence
Industry
Pharmaceutical Manufacturing
Company size
201-500 employees
Headquarters
Toronto, Ontario
LinkedIn followers
41,286
PharmEng Technology, now part of Efor Group, leader in Compliance Engineering, is a leading provider of technical services and solutions to the pharmaceutical, biotechnology, and healthcare industries. With over 25 years of experience, we specialize in Commissioning, Qualification, and Validation (CQV) services for facilities, utilities, equipment, and processes.
As part of Efor’s global network of 3,000 experts across 12 countries, we are better equipped than ever to deliver innovative and comprehensive solutions tailored to the unique needs of clients worldwide. This integration strengthens our ability to combine global expertise with local proximity, positioning PharmEng as a strategic partner for the industry’s most prominent players.
Our team of highly skilled professionals brings a wealth of industry expertise and knowledge to every project, ensuring that our clients receive the highest quality services and solutions. We pride ourselves on our ability to provide flexible, innovative, and cost-effective solutions that meet our clients' unique challenges.
At PharmEng Technology by Efor, we are committed to delivering excellence in everything we do. We work closely with our clients to understand their goals and objectives, developing customized solutions that deliver measurable results. Our focus on quality, safety, and compliance ensures that our clients can trust us to meet their most critical needs.
Specialties: PharmEng Technology specializes in the planning, design, construction, and validation of Health Care, Laboratory, API Pharmaceutical, and Biotechnology facilities and equipment, including computer systems. We provide professional services that meet both regulatory and business demands, following current Good Manufacturing Practices (cGMP), Good Engineering Practices (GEP), and Good Laboratory Practices (GLP).
Offices: 23 Lesmill Road, Suite 410, Toronto, Ontario M3B 3P6, CA · 2475 Northwinds Parkway, Suite 200, Alpharetta, Georgia 30009, US · 2500 Regency Pkwy, Cary, North Carolina 27518, US · 866 Yuhangtang Road, Hangzhou, CN · 116c 2F Quang Trung Street, Haoni City, VN
How many Engineering jobs are open in Madrid, Spain right now?
There are currently 1,182 open engineering positions in Madrid, Spain listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Engineering roles in Madrid, Spain?
Companies currently hiring include ACCIONA, Capgemini, knowmad mood, Indra Group USA, Roche, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Engineering jobs in Madrid, Spain?
Yes — 642 of the 1182 open engineering positions offer remote or hybrid work (177 remote, 465 hybrid).
How do I apply for Engineering jobs in Madrid, Spain?
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