Engineer Manufacturing Compliance
vor 14 Stunden
Direct message the job poster from Gi Group
For our partner in the Pharmaceutical industry, in the Canton of Neuchâtel,
Gi Life Sciences is looking for an:
Engineer Manufacturing & Compliance
(Temporary contract)
Your mission:
This role will support the Head of Packaging Operations in monitoring quality and performance metrics while acting as a referee for the operational team for GMP systems, documentation, and training.
You will be in charge of authoring, owning and leading updates of GMP documents/projects related to Bulk, Packaging and/or Warehouse operations. Additionally, initiating and owning deviations assessments and participating to investigation tasks as required.
Your responsibilities:
- Initiate deviations and participate to investigations.
- Follow up and implement assigned CAPA’s.
- Author and review manufacturing documents, including specifications, working practices, SOPs, forms and logbooks. Follow up approval flow within electronic documentation system.
- Lead or support manufacturing projects (new equipment, process change, etc…) by managing the documentation associated with the project (URS, Protocol, Change Control, etc…)
- Ensure distribution and withdrawal of GMP documents in manufacturing area.
- Participate or lead technical aspects for specific projects (SAT, FAT, Technical visit at the supplier or on site) to bring technical expertise.
- Act as quality system and GMP Documentation referee for the Manufacturing Packaging Ops Team and as a key representative for QA Ops.
- Support the team in proactively monitoring quality, safety and performance / reporting metrics (OEE, Tier Meeting) and in proposing improvement measures.
- Act as the back-up of other Engineer Manufacturing & Compliance in Bulk and Warehouse departments.
- Lead risk assessments, data integrity risk assessment and risk management within cross functional teams (from draft to approval).
- Perform complaint investigations and manage the defect library process and the related training for the site.
Your profile:
- BS/MS in Engineering/Technical discipline or equivalent experience.
- 7 years’ experience in pharmaceutical validation, packaging, drug manufacturing process or related field.
- Sound knowledge of current international regulatory regulations, cGxP requirements and best practices, including 21 CFR part 11, 210 and 211, Annex 11, EU-GMP guidelines and GAMP.
- Experienced in Health Authority inspections (preparation, process, presentations, responses drafting, etc.).
- Knowledge of pharmaceutical facilities, manufacturing, and laboratory systems and processes especially in Oral Solid Dosage form (OSD).
- Well-developed ability to constructively work across functional areas and levels to achieve results.
- Strong verbal and written communication skills.
- Strong analytical, problem solving, influential and deductive skills.
- Capability to work with short deadlines and simultaneous activities.
- Excellent organizational and project management skills.
- Fluent in English and in French.
- Associate
- Temporary
- Science
- Pharmaceutical Manufacturing
-
Manufacturing Engineer FF
vor 3 Wochen
Neuenburg, Schweiz Takeda VollzeitJob Title: Manufacturing Engineer Location: CHE - Neuchâtel Primary Duties: Within the Manufacturing department, reporting to Deviation Experts Supervisor, the primary mission for the Manufacturing Engineer is to support the manufacturing operations to meet their goals in terms of quality and productivity. He/she specifically provides technical expertise...
-
Manufacturing Engineer
vor 2 Monaten
Neuenburg, Schweiz Takeda VollzeitDescription À propos du poste:Manufacturing Engineer “CSV & Data integrity Specialist”«Spécialisé dans la gestion des Systèmes Informatisés et Systèmes Automatisés de production »Au sein du département « IT Manufacturing» du site de production de Neuchâtel (approx. 700 collaborateurs), dans le secteur de l’hématologie, nous recherchons un...
-
Senior Process Engineer
vor 3 Wochen
Neuenburg, Neuenburg, Schweiz CK Group VollzeitJob Title: Senior Process EngineerWe are seeking an experienced Senior Process Engineer to join our team at CK Group in Neuchatel. This is a contract-based position for 12 months.About the Role:This senior process engineer role offers a unique opportunity to work with a global pharmaceutical company, providing manufacturing support activities, projects...
-
Bio Process Engineer
vor 2 Wochen
Neuenburg, Neuenburg, Schweiz Gi Group SA VollzeitAt Gi Group SA, we are seeking an experienced Bio Process Engineer to join our team in the pharmaceutical industry. This is a temporary long-term contract opportunity.As a Bio Process Engineer, you will be responsible for providing technical support to technology transfer and commercial operations related to biological drug substance upstream cell culture...
-
Senior MS&T Engineer
Vor 5 Tagen
Neuenburg, Schweiz BioTalent Vollzeit2 days ago Be among the first 25 applicantsDirect message the job poster from BioTalentSenior Consultant - Key Account Management at BioTalent, part of The IN Group | R&D within Life Sciences - UK/EU/USPermanent - full-timeAre you a seasoned professional in the pharmaceutical industry looking to take your expertise to the next level?BioTalent have teamed up...
-
Neuenburg, Neuenburg, Schweiz CK Group VollzeitAbout the RoleWe are seeking a skilled Senior Pharmaceutical Process Development Engineer to join our global team in Neuchatel, Switzerland. This 12-month contract position will provide an exciting opportunity to contribute to the development of pharmaceutical processes and products.Job DescriptionThe successful candidate will be responsible for leading...
-
MS Process Engineer
Vor 5 Tagen
Neuenburg, Schweiz Aristo Group VollzeitDirect message the job poster from Aristo GroupMSP Lead | MSP Partnering at Aristo Group | Empowering Life Science with the Perfect MatchJob title: MS Process Engineer (Fill and Finish) (m/w/d)Skills: MS Process EngineerStart of project: asapDuration of the project: 12 monthsPrimary ResponsibilitiesLead process improvement projects and optimize process...
-
Senior Process Engineer
vor 1 Woche
Neuenburg, Neuenburg, Schweiz CK Group VollzeitWe are seeking a highly skilled Senior Process Engineer to join our team in Neuchatel, Switzerland. As a key member of our team, you will be responsible for leading process improvement projects, developing and optimizing process parameters, and ensuring process performances through Quality by Design (QbD) and Continuous Process Verification (CPV)...
-
Neuenburg, Neuenburg, Schweiz CK Group VollzeitCompany OverviewCK Group is a leading pharmaceutical company with a global presence, committed to delivering high-quality products and services. Our team of experts works tirelessly to ensure the highest standards of quality and compliance in all aspects of our business.Job DescriptionWe are seeking an experienced Process Engineer to join our team in...
-
MS Process Engineer
vor 1 Monat
Neuenburg, Schweiz CK Group VollzeitMS Process EngineerCK QLS are looking for a senior process engineer to join a global pharmaceutical company, based in Neuchatel, on a contract basis for 12 months.Position: MS Process Engineer Formulation, Fill and Finishing, NeuchatelDuration: 12 monthsMain Responsibilities:Manufacturing support activities (deviation, process follow-up) - 45% of the...
-
Validation Engineer
vor 14 Stunden
Neuenburg, Schweiz LHH VollzeitI am looking for my client, a medical device manufacturer based in the canton of Neuchatel, for a Validation Engineer for a temporary (long term) contract.Your responsibilities:Generation and execution of qualification/validation protocols including the generation, routing, and approval of summary documentation.Work with project teams to develop DOEs and...
-
Senior Digital Design Engineer
vor 13 Stunden
Neuenburg, Schweiz European Tech Recruit Vollzeit23 hours ago Be among the first 25 applicantsDirect message the job poster from European Tech RecruitSenior Consultant at European Tech Recruit | Technical Recruitment ExpertWe are proud to be partnered with a global leading semiconductor company, who focus on power and sensing technologies for a safer, cleaner, and smarter world.They are looking for an...
-
Process Engineer
vor 1 Monat
Neuenburg, Schweiz Freudenberg Group VollzeitWorking at Freudenberg: We will wow your world!Responsibilities:Global project management according to RACI for all Vibracoustic inhouse process stepsPreparation of technical and calculative manufacturing concepts (Process Maps)Selection, evaluation and implementation of new manufacturing technologiesPreparing of specification sheets and obtaining quotations...
-
Digital Design Engineer
Vor 5 Tagen
Neuenburg, Schweiz European Tech Recruit VollzeitSenior Consultant | Semiconductor, Automotive, Software EngineeringA fantastic opportunity for a skilled Digital Design engineer to join a global leading semiconductor company, who are developing silicon solutions which help improve lives around the world.You will be part of a team developing low power DSP systems, secure Bluetooth MCUs, and dependable...
-
Process validation engineer
vor 14 Stunden
Neuenburg, Schweiz Antaes Consulting VollzeitDirect message the job poster from Antaes ConsultingTo join our Life sciences team in Neuchâtel, we are looking for a MSAT Validation Senior Scientist (F/M).Your Role :Develop, implement and manage the site process validation, and revalidation strategies to meet cGMP and quality requirements on time and on budget to ensure that programs are compliant with...
-
Senior Quality Assurance Specialist
Vor 5 Tagen
Neuenburg, Schweiz Panda International VollzeitDirect message the job poster from Panda InternationalAssociate Recruitment Consultant @ PandaTogether with our key big pharma client in Neuchâtel, Switzerland we are looking for a Senior QA Expert to act as the key member of their Quality Assurance team, ensuring compliance and quality oversight of manufacturing and release processes for bulk drug...
-
Digital Design Engineer
vor 13 Stunden
Neuenburg, Schweiz European Tech Recruit VollzeitDigital Design Engineer - Digital Compute Team - Senior, Staff, Principal I am partnered with a multinational semiconductor firm at their European Center of Excellence in Neuchatel (Switzerland), who are looking to expand their digital design team, with multiple positions, at varied levels of seniority. Please note: This is an onsite position in...
-
CAD Layout Engineer
vor 2 Monaten
Neuenburg, Schweiz Microtech Global Ltd VollzeitPosition:CAD Layout EngineerLocation:Neuchatel, SwitzerlandEmployment:PermanentCompany Overview:My client’s “Integrated & Wireless Systems” Business Unit based in Neuchâtel, Switzerland, is currently looking for CAD Layout R&D Engineer.About the company's mission and values:Their mission is the development and transfer of innovative technologies to...
-
MS Process Engineer Formulation, Fill and Finishing
vor 3 Wochen
Neuenburg, Schweiz Randstad (Schweiz) AG VollzeitJob DescriptionFor our client, an international pharma company based in Neuchâtel, we are looking for an MS Process Engineer Formulation, Fill and Finishing.General Information:Start date: 06.01.2025End date: 31.12.2025Workplace: NeuchâtelWorkload: 100%Home office: possible up to 3 days per week, but during the first 2-3 weeks onsite presence required full...
-
R&D Engineer Surface Engineering
vor 14 Stunden
Neuenburg, Schweiz CSEM SA VollzeitFacing the Challenges of our timeHelp us grow and be more impactful!The Micro and Nano Systems Business Unit, based in Neuchâtel, Switzerland is looking for a R&D Engineer in Surface Engineering (fixed term position of 2 years).Your missionAs an R&D Engineer, you will be integral to our research and development efforts focusing on the elaboration of...