(Sr.) CSV Manager (m/f/x) | Mainz Area | Pharma

As CSV Manager (m/f/x), you are responsible for managing the IT Validation capability within the IT Assurance function. You are part of the Global IT Organization. These tasks are waiting for you:Collaborate closely with all Global IT departments to ensure that validated environments comply with GMP and other regulatory standards relevant to MedTechOversee, execute, and manage all computer software validation operations within the Global IT organizationEnsure the preparation, review, and approval of validation documentation, including CSV/CSA risk assessments, change control forms, validation plans, data migration strategies, IQ, OQ, PQ/UAT test protocols and reportsConduct an initial Quality Gate assessment when new applications or software are introduced to determine if validation is necessaryOffer guidance to Global IT projects and programs regarding validation processesConduct audits to verify that governance and change management protocols are properly implemented This completes your profile:Bachelor's degree in Life Sciences, Computer Science, Business, or a related field (or equivalent relevant experience preferred)3+ years of experience in computer system validation, ideally within the Life Science industryFamiliarity with quality risk management and GxP regulatory frameworksBackground in project managementProven track record working in a global, multi-divisional technology settingStrong knowledge and practical application of FDA regulations and other compliance standardsFluent English skills and good German skills This is what the position offers you:Flexible working hoursA comprehensive company pension schemeRegular training coursesFree parking or a ticket for the Hamburg public transport networkHealth care and medical check-upsA staff restaurant and subsidized lunches30 days of holiday time each year Information about our client: The company is a global company focusing on minimally invasive therapies for Medical Devices and Life Sciences with an IT team that is globally connected and drives innovation. They encourage a collaborative environment and are looking for curious personalities to improve people's lives together.

As CSV Lead (m/f/x), you are responsible for managing the IT Validation strategies and provide guidance to other departments and sites in relation to the Computer System Validation. These tasks are waiting for you:Responsible for Quality Management of IT systems implementation projectsEnsure compliance with regulatory requirements such as 21 CFR Part 11, GMP Annex 11, GAMP5 guidelinesDevelopment of design requirements for new electronic business solutions in a GxP environmentExecution and creation of validation and testing strategiesOversee the review, enhancement, and implementation of IT quality processes, standards, and systemsOptimization of the processes and life cycle in relation to the global validationLead and execute internal and external audits, with accountability for managing IT service providers and ensuring supplier compliance This completes your profile:Studies in Life Sciences, Computer Science, Business, or a related field (or equivalent relevant experience preferred)Several years of experience in computer system validationFamiliarity with quality risk management and GxP regulatory frameworksStrong knowledge and practical application of FDA and EU regulations and other compliance standardsFluent German and English skills This is what the position offers you:Exciting work environment, where you can implement your expertiseAttractive salary compensationInnovative approachFlexible working hours30 days of holiday time each year Information about our client: A global contract manufacturer specializing in pharmaceuticals, providing comprehensive services from active ingredient production to final drug packaging. It supports pharmaceutical and biotech companies in key therapeutic areas like oncology, cardiology, and rare diseases, with a strong focus on quality and regulatory compliance across its international facilities.

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