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.

SciPro are exclusively partnered with a leading, global pharmaceutical company with a culture of patient centricity, supporting their search for a Risk Management Pharmacovigilance Specialist. This role supports the QPPV office and DSPV functions on the oversight and finalization of RMP and RMMs as a subject matter expert within the EMEA PV team. Within the role, you will ensure compliance with global PV regulations, lead effective implementation of local and regional RMPs with a critical mindset to continuously improve existing processes, whilst contributing to the development of new procedures in close collaboration with global stakeholders.Key responsibilities:Support the finalization of RMPs and RMMs including relevant material.Assist Medical Safety leadership and MSLs with compliance oversight and tracking tool planning and oversight of RMP commitments.Support QPPV team in strategic impact assessment of PV regulations intelligence items.Key Requirements:Knowledge of worldwide RMP regulations: prior experience with European Union (EU) regulations is required.Exposure to working relationships with regulatory authorities.Demonstrable, hands on experience of implementing local and regional RMPsAbility to independently lead long- and short-term project timelines and deliverables.

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