(Sr.) CSV Manager (m/f/x) | Mainz Area | PharmaJoin a trusted and innovative pharmaceutical company as a key expert (m/f/x) in computer system validation. Your expertise will guide essential validation processes, and you'll engage in exciting projects that make a real difference in advancing healthcare solutions. These tasks are waiting for you: Planning, coordination, and execution of computer system validation in compliance with current regulationsEnsuring regulatory compliance throughout all stages of computer system validationConducting risk management within the scope of computer system validation (CSV)Managing all documentation generated during validation projectsPreparing final validation reports and ensuring data and system securityPlanning, supervising, and monitoring validation, qualification, and calibration activitiesCoordinating and overseeing deviation managementPreparing and reviewing GMP-related documentationSupport in external auditsThis completes your profile:Degree in Computer Sciences or comparable qualifications with relevant work experience4+ years of professional experience in a CSV role, preferably in the pharmaceutical industry or medical device industryIn-depth knowledge of regulatory requirements (GxP, CFR 21 Part 11/EU GMP Annex 11, GAMP5)Excellent communication skills and a methodical, quality-focused approach to workFluency in both German and EnglishBenefits:Flexible working hours with 30 days of holidayPersonal and professional developmentHealth offers such as JobRad, Wellpass, and sports groupsCollaborative and appreciative work environment, with flat hierarchies Information about our client: Our client is a well-established company in the pharmaceutical industry, offering end-to-end services across drug development, manufacturing, and supply chain management. Known for quality and innovation, the company provides a collaborative work environment focused on efficiency and quick decision-making, supported by a close-knit, professional culture.

SciPro is currently partnered with a clinical-stage biotechnology company targeting novel drug delivery platforms. The company is looking for a formulation subject matter expert to join the Technical Operations team and contribute to formulation development, scale-up, and tech transfer activities.   Responsibilities: Formulate novel inhalation drug delivery platforms Manage raw material development and preformulation through late-stage process development Process design and development for drug product manufacturing Coordinate with other cross functional CMC teams   Qualifications: PhD in Biochemistry, Chemical Engineering, or related field with ideally 3+ years of industry experience (combined experience in biotech and pharmaceutical environment is ideal) Hands on experience working with inhalable drug delivery formats   All interested applicants are encouraged to apply below.

SciPro is currently partnered with a clinical-stage biotechnology company targeting novel drug delivery platforms. The company is looking for a formulation subject matter expert to join the Technical Operations team and lead all drug product development strategy.   Responsibilities: Lead a small team of formulation scientists working inhalation drug delivery platforms Oversee raw material development and preformulation through late-stage process development Coordinate with other cross functional CMC teams   Qualifications: PhD in Biochemistry, Chemical Engineering, or related field with ideally 12+ years of industry experience (combined experience in biotech and pharmaceutical environment is ideal) Hands on experience working with inhalable drug delivery formats People leadership experience strongly preferred   All interested applicants are encouraged to apply below.

Engineering / Capital Project Manager Raleigh NC   PROFILE:   This individual will develop, implement, and oversee capital projects and equipment purchases to support biopharmaceutical Operations. This role is focused on managing projects ranging in size of up to $5 million. Duties include interfacing with cross-functionally with both internal teams and groups, and external suppliers to ensure projects are delivered on time and within budget. This position will utilize breadth of knowledge across facilities and engineering to ensure regulatory compliance and effective project execution   REQUIRED COMPETENCIES   Strong pharmaceutical project management skills and proven experience in having managed capital projects with emphasis on Biologics, clinical and/or manufacturing and development laboratories in a cGMP environment. Project Management skills including the development and management of work breakdown structures, RACI diagrams, schedules, budgets, action trackers and meeting minutes. Understanding of GMP, regulatory, environmental, and OSHA regulations as it relates to Engineering, Facilities Operations and Construction Understanding of financial management as it relates to capital and expense spending and project cash flow forecasting. (i.e. Purchase Orders, Invoicing) Experience in total project delivery in a cGMP environment (from concept to validation and startup process). Leads the development of the capital project scope and objectives in support of the business strategy dealing with clients and stakeholders. Exhibits project leadership and effective decision making throughout each project. Leads and promotes effective teamwork by engaging both Facilities as well as including key clients and stakeholders.   QUALIFICATIONS & EXPERIENCE:   BSc in Engineering or equialvent discipline Previous cGMP Project Management experience Right to work in the USA without Sponsorship

Senior Validation Engineer (Contract) Location: Van Nuys Area Role Overview We're seeking a highly skilled Senior Validation Engineer for a temporary onsite role. Reporting to the Manager of Quality Engineering, you'll support our quality engineering team with documentation and validation tasks for automation projects. You'll also draft design specifications, conduct validation testing, and collaborate with various internal departments and external vendors to ensure smooth project execution. Key Responsibilities Draft and review documentation, including user requirements, design specifications, and testing protocols. Conduct hands-on validation for automation projects and address protocol discrepancies. Work with internal departments and external vendors to establish schedules and coordinate validation activities. Attend project meetings and communicate status updates to relevant stakeholders. Perform project management tasks and escalate issues to leadership as needed. Qualifications Bachelor's Degree and a minimum of 5 years of experience in Quality and/or Manufacturing within pharmaceutical, biotechnology, biologics, or cell therapy industries. Strong knowledge of equipment and computerized systems, with an understanding of data integrity and change control management. Excellent interpersonal and technical writing skills. Experience with automation equipment, bioreactors, temperature-controlled units, and cell processing systems is preferred. Proficiency in Microsoft Office tools, including PowerPoint, MS Project, Excel, and Word. Ability to work collaboratively across departments and with external vendors.