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Full-time
bachelor degree, postgraduate degree
Competitive Compensation, Professional Development, Career Growth
Posted 2h ago
~40 hrs/week
Responsibilities
Lead end-to-end project execution for sterile injectable drug products, focusing on aseptic manufacturing and technology transfer. Coordinate cross-functional teams to ensure milestones are met in compliance with global regulatory standards and GMP.
Requirements
Requires a degree in Pharmacy, Chemistry, Biotechnology, or Engineering with at least 5 years of project management experience in sterile pharmaceutical manufacturing. Fluency in both Spanish and English is mandatory.
Full job description
Position Title: PROJECT MANAGER
Location: Madrid
Type of Contract: Full-Time
Position Summary
The Project Manager is responsible for leading cross-functional projects related to sterile injectable drug products. The role ensures timely delivery of milestones in compliance with GMP, global regulatory standards, and internal quality systems, with a strong focus on Quality Assurance, CAPA governance, and team leadership.
The PM will act as a key point of coordination and monitoring, ensuring the efficient execution and fulfillment of the strategic objectives of technical transfer projects.
This position may require travel lasting two to three months.
Fluent in Spanish and English are mandatory for this position.
Key Responsibilities
Lead end-to-end project execution for injectable drug products, aseptic manufacturing processing, fill-finish operations and packaging.
Ensure, together with the Business Unit Head (BUH), that the necessary capacity exists to meet project milestones.
Assess potential time or capacity constraints in advance to identify and implement mitigation plans in a timely manner.
Coordinate post-technical transfer activities, ensuring the successful launch of the product.
Coordinate cross-functional teams (R&D, QA, QC, Regulatory Affairs, Engineering, Manufacturing, Supply Chain) to meet project milestones.
Develop and manage detailed project plans, timelines, budgets, and risk mitigation strategies.
Ensure compliance with global regulatory requirements (FDA, EMA, WHO) and GMP standards for sterile products.
Oversee technology transfer activities between development sites and commercial manufacturing facilities.
Support validation activities (equipment, process, cleaning) and readiness for regulatory inspections.
Lead and track Change Control processes related to equipment, documentation, and process modifications.
Manage and resolve CAPAs in collaboration with QA and operational teams, ensuring timely closure and effectiveness verification.
Provide leadership and guidance to project team members, fostering collaboration, accountability, and performance.
Facilitate project meetings, generate progress reports, and communicate updates to senior leadership.
Qualifications
Bachelors or masters degree in Pharmacy, Chemistry, Biotechnology, Engineering, or related field.
Minimum 5 years of experience in project management within sterile pharmaceutical manufacturing.
Strong understanding of aseptic processing, terminal sterilization, and cleanroom operations.
Proven track record managing injectable products, tech transfer, and QA-related activities.
Hands-on experience with CAPA systems, Change Control management, and quality documentation workflows.
PMP certification or equivalent is a strong asset.
Fluent in Spanish and English (native or high professional level required).
Preferred Experience
Experience with high-potency APIs, biologics, or complex injectable formulations.
Familiarity with Annex 1 (EU GMP) and 21 CFR Part 211 compliance.
Knowledge of regulatory submission processes (IND, NDA, MAA).
Exposure to Lean, Six Sigma, or Agile methodologies.
What We Offer
Competitive compensation and benefits
Opportunity to lead high-impact injectable drug programs
Collaborative and innovation-driven work environment
Professional development and career growth
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.
Related keywords
Sterile InjectablesGMPFDAEMAWHOCAPAChange ControlAseptic ProcessingTerminal SterilizationCleanroom OperationsAnnex 121 CFR Part 211INDNDAMAALean
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
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