Based on your estimated location we can supply the following candidates:
MES Lead – Pharmaceutical (INS-6583)
MES Lead Project Manager with strong pharmaceutical background and extended IT knowledge; PMP-ACP Certified, Emerson Syncade, NUI Galway, PAS|X 3.1.4 and 3.1.7, 70-461 Querying Microsoft SQL Server, Allen Bradley and Siemens PLC Programming, Siemens S7-300, S5, S7, RS Logix, PCS 7, Steps 7, SCADA, HMI, ABB, profibus, Ethernet, Cat 6 networking, VLAN, SLA agreements using ITIL, Rockwell MES, Aspen-Tech, Aspen InfoPlus.21, Beckham and Elau systems, SharePoint Administrator, Wonderware, FactoryTalk Transition Manager, GAMP 5, 21 CFR Part 11 assessments, IQ/OQ/PQ for software and hardware, ISPE Computer Validation, V&V, Commissioning, Cerity Software, SAP, SAP-PI, S88 and S95 standards within CoE group, ePES replacement.
Responsibilities: MES for KPI criteria, document project charter, compliance plan, business cases, URS, costing and scheduling, risk assessments, FMEA, EP and USP guidelines, FDA and IMB audits, integrate MES system into LIMS, BMS and ERP systems, Change control management, FAT, MES project manager for roll in USA and other global sites.
Pharmaceutical areas: Tablet press, sterile enzyme production, CIP – Clean in Place System, cleaning validation, WFI, PW and HPW, Packaging Lines, Vision System, Blender and Material handling units, laboratories, FTIR, HPLC and GC.
Education: M.Sc. Science in Software and Information Systems, Chemistry with Quality Management
Rockwell & MES Lead – Pharmaceutical Industy (INS-6516)
Project Manager Automation with years of experience from the pharmaceutical production industry including Consulting Engineering within SCADA, MES, Rockwell and validation. Other professional skill; Profibus, Wonderware, Modbus, Allen Bradley, PLC Programming, Instrumentation, Process Optimization, Automation and Control, Commissioning, Continuous Improvement, Lean Manufacturing, Change Control, Technology Transfer, Control Logic, CAPA, SOP, V&V, R&D, QC/QA, HMIs Hazardous Materials Identification System, P&ID, DCS, GAMP, GMP/GxP, ISO standards, FDA, 21 CFR Part 11.
Education: M.Sc. Mechanical Engineer, Automation, DTU
Engineer CE-Marking (INS-3277)
Electrical Engineer with 20 years’ experience in CE-marking and machine safety; holds a Bachelor in Electrical Engineering and has a hand-on approach as former electrician, with a broad knowledge in; process optimization, production projects, issue solving, risk assessment, machinery inspection, troubleshooting and machine safety of all kinds. Furthermore, a valuable resource in teaching electrician and other employees in machine safety including employees during his work at Novo Nordisk and NNE Pharmaplan.
Automation Engineer (INS-0164)
Automation Engineer with profound industry knowledge; project planning, budget estimation, compiling of technical quotes, detailed design drawings, procurement support, commissioning and general writing and evaluation of project documentation. Pharmaceutical GMP experience within SattLine/Delta V and robot technology. In depth knowledge about sensors and inverters. A team player who coordinates across the organisation. Experienced in build-up, maintenance and optimization of processes within PLC, SCADA (HMI/RTU) and related protocols as well as in PCS systems, PLC programming and configuration. Diagram layout within several different systems. Knows of automation of industry standards. Education: M.Sc. Electronical Engeneering.
Quality Control – Management (INS 6412)
Mechanical engineer with a PhD degree 23 years’ experience in various industrial fields. Have been responsible for several product lines complying with international standards for food industry such as ISO 22000 and HACCP. Managing staff and planning their daily tasks. General monitoring and assessment of production lines on a daily, weekly and monthly basis. Reporting quality parameters of products often direct to the chairman of board. Experience with pipe design and PLC controlled cleaning-in-place (CIP) and other sanitation of storage and process tanks, pipe system, cooling equipment and processing machinery using caustic soda (alkali), nitric acid, and hot water.
Technical experienced team leader with 7 years of experience from the medical device- og pharmaceutical industry. A team leader who works cross organizational and plans resource allocation for the production work in cooperation with logistic functions. Well known for optimizing processes in the execution of production while cooperating with the rest of the organization as well as taking care of professional- and personal development within the area of responsibility. All this compliments the expertise within HR administration, personal management, time monitoring, absence, vacation and conflict management. Education: Toolmaker.
Senior Automation Supporter – Pharmaceutical (INS 6519)
Senior Automations Technician, 12 years’ experience from pharmaceutical process industries. GMP classified aseptic filling. 21CFR Part1. Development, programming, implementation, maintenance and compliance of larger PLC controls systems (S7) and full automatic production equipment; process lines, filling machines, storage tanks, packaging machines, cartoning machines, tablet machines, coater, blister machines, ventilation (humidity and temperature-monitoring) and other utilities systems. Procurement of parts. Preparation of various instruction. Education of technician and process operators. Leading external electrician. FMS supporter. Performing IQ of software/hardware baseline and OQ validations. Project management on state of the art full automatic material handling system. Using LEAN tools at all levels. Preparing SOP, CR (Change Request/Change Control), test protocols. Performing commissioning, validation and testing of equipment. PLC: Allen Bradley, Omron and Siemens connected with PLC network, Device-net and Ethernet. Electrical-drawings by CADdy, SEE ++. Maintenance system PC-based Logihold and PEMAC. Good insight in Machinery Directive and SB (Stærkstrøms Bekendtgørelsen). Participation in Development Committee of EVU. Part in laying out new electrician education material per 2015. CTS monitoring, developing and programming.
Senior Product Developer – Medical Device (INS-0617)
Senior consultant, 10 years of experience in new product development including disciplins such as; product design, packaging, equipment for production and automation of processes. Helps companies by bringing their product suggestions from idea to reality. Experienced within handling challenges revolving around ease of use, analysis, design details, choice of materials, method of production, mould design and production processes, packaging etc. Acknowledged consultant within strategy, production methods and product development. Education: M.Sc., Mechanics / Executive MBA.
Architecture & Planning (INS-0116)
Technical and professional experienced assistant holding 9 years of experience within Facility Management, database administration, international documentation management, Revit Architecture, AutoCAD and teamwork. Many years of cooperation with architects and engineers as well as with staff members that hold no professional background within building. Education: Technical Drawing.
Medical Devices – Senior (INS-0262)
Civil engineer Ph.D, 15 years of experience with the establishment of production of newly developed products, transactional experience with product development nationally and internationally for both multi usable devices and disposable equipment. Cooperation with suppliers, negotiation of contracts and cost prices. A consultant with extensive experience, project management, personnel management, strategy work, economic analysis and decision-making material for managements and boards. The perfect coaching for your young team. Education: Civil Engineering/Bachelor of Commerce/Ph. D Mechanical and electrochemical Processes
Executive Leader – Medical Device (INS-1012)
Leader with 20 years of international experience, production management, daily operation, logistics, quality, strategic, project and interim management as Chief Financial Officer, CFO, group management and Board of Directors. Furthermore, supplier management and budget analysis and optimization. Motivational and committed leader who delegates and creates creative transformation that quickly leads to stable dividends. Education: Master of Science (m.SC.) Engineering/Industrial management
AD Webdesigner & Service Design (INS-1067)
15 years of publishing experience as a leader in 4 advertising bureaus. Experienced document and Web Developer and Designer within WordPress, Joomla and Drupal but know most CMS systems from Adobe to Microsoft including 3D Design, 3D Studio, AutoCad, etc. everything from managing HR, Webshop and generally as a designer for product logos, company logos and production of packaging. Education: MS.IT
QA Engineer (INS-0633)
Quality Assistant who has 12 years of experience with the release of raw materials, product inspection in the production area and release of finished goods. Review and approval of Batch Certificate of Conformance for raw materials for production. Collection of various documentation from producers, management of quality reports batch documentation and API reports. Authentication of user manuals. Maintenance of the quality manual. Handling of deviations and complaints. Appreciates cross cooperation and to learn new areas. Education: Cand. Scient.
Junior Engineer (INS-1093)
Systematic analytical chemist for the solution of a wide range of analytical tasks in chemical analysis, troubleshooting and problem solving. Experience with systematic review of factors that can affect the product negatively. Knowledge of optimization of HPLC Analysis, day-to-day operations of the laboratory and problem solving during industrial production of new product lines. Interest for project work in the analysis and development of chemical products with the use of the following areas of competence; analytical chemistry, problem analysis, optimization, data analysis, development tasks. Like to work with new areas and technologies. Education: master of science in Chemistry.
Senior Publishing Expert or HR Expert (INS-1144)
25 years experience as President, VP, board member, interim leader. Branches PR, HR, IT and Life Science. He has worked as consultant and had only large account customers (TOP100 in Denmark). The experience of IT also covers Server Hosting, IT Outsourcing, Hacking, 3D Software, CAD/PLC, SAP and as a Microsoft Certified Professional. Can also work as an experienced HR Manager.
Senior Engineer – Validation (INS-0832)
Experienced Senior Validation engineer with technical and commercial experience in process and pharma industry. Several years of experience with project management, document control, consultancy work and qualification of equipment. In the work, national and international regulatory requirements are complied with. Especially within the field of validation the experience covers preparation of detailed project descriptions, project management and validation. Experience with converting/automation of existing production facilities as well. Has through advisory secured FDA approval of medical devices on the us market as well as participated in the design of new production facilities, drafting of qualification documentation and vendor agreements. Education: BSc. Mechanical Engineering
Senior Sourcing (INS-0876)
More than 30 years of experience in technology and sourcing in an international environment, including label, print, surface treatment, plastic, metal parts and deep drawing processes. Experience in supplier management, both in the field of mechanics and technology. A project manager who understands PMI-methods validation & compliance in relation to the FDA requirements. Specialist in the field of process validation, cross-cultural cooperation with focus on Asia, including China. Many years of experience in product development, production and process analysis, practical quality assurance, sourcing and procurement in General. Ability to make complicated projects ready for production. Practitioner in LEAN and Six Sigma. Empowered by sharing experience, creativity, know-how and competences in order to influence, strengthen and inform stakeholders. Education: BSc. Engineering, BSc. Mechanics
PhD Pharmacist Researcher (INS-0888)
PhD in the field of Pharmaceutical Science with author of several releases. The professional experience covers work and research in several countries such as United States, with a focus on molecular biology and the pharmaceutical area. Core competencies cover project management, problem solving based on robust analytical thinking, scientific writing and oral presentations as well as internationally and cross-functional collaboration. In addition, all professional activities are performed with a mind-set that puts quality at first. The linguistic competences cover Danish, fluent English and Chinese. Education: Ph.d. Pharmaceutical Sciences, M.Sc. in Molecular Biology
Senior Sales Manager (INS-0356)
Many years of experience in sales and marketing for several international companies and major Danish advertising agencies. Recognized lecturer in communication, sales and service, as well as known among clients as a highly effective speaker. Analysis, inspiration plus the development of people skills are among the core competencies and forms the basis for initiation of processes which paves the way towards the goal. In this work the human is in focus through a trusting and sympathetic approach, which quickly and conveniently uncovers and highlights any needs. This approach has led to the achievement of significant results throughout the career.
Senior Pharmacist (INS-0537)
More than 30 years experience in pharma and biotech industry in production, formulation, and QA. Thorough knowledge of work with salary/contract filling (CMO). In roles as senior manager, technical director, production Director, he has among other things, handled; the securing of durable product formulations and processes, process optimization, troubleshooting production survey, causal analyses & CAPA as well as participated in Change management processes. Experienced in technical support, information and documentation within regulatory requirements/regulatory requirements for archiving. Great knowledge of product development, manufacturing setup, product implementation, packaging, and business development. Has secured the establishment and operation of external production to commercial scale and product optimisation with focus on quality, economy and end user compliance. Education: M.Sc. Pharmacy.
MSc in Biology – Microbiology (INS-0663)
More than 4 years of experience as a laboratory technician & microbiological specialist with expertise in medical lab technology within micro biology & bacteriology, Chemistry and Biochemistry, molecular and cell biology, bacterial infection & Biofilm, QC microbiology, hematology, immunology, parasitology, GLP and ELISA. Moreover, experience in environmental microbiology in water, bioremediation & biodegradability as well as in herbal medicine against bacteria with antibiotic resistance. In addition, pharmaceutical knowledge of GMP and Food and Drug safety (FDS). Education
: MSc in Biology – Microbiology
Pharmaconomist – Aseptic Processing (INS-1087)
Pharmacist with over 20 years’ experience in the Pharmaceutical Industry including production and aseptic processing. Expert in Cleanroom Environmental Monitoring, Batch Record and Process Qualification Data Review: Also experience with Cleaning Validation, Quality Management, SOP, Change Control. Only available for part time tasks. Education: Pharmaconomist – Copenhagen
QA Engineer – Process Validation (INS-0964)
Mechanical / Mechatronics Engineer with 8 years of experience in medical process, liquid, gasses and equipment manufacturing industry. He has several skills within; quality assurance, product development, production methods, process flows, CE-marking, process and product validation. He is familiar with standards and industrial requirements and follow engineering principles to quickly learning about new materials, equipment, devices and processes. Education: M.Sc. in Mechatronics Engineering / B.Sc. in Mechanical Engineering
Industrial Engineer – Construction – B2B – Sales (INS 0478)
Industrial B2B Engineer with 14 years of experience with in the construction industry and reference to well-known Scandinavian and International construction companies. A manager with focus on B2B, Sales & Marketing where skills including Management, Strategic Planning, Negotiation, Customer Service, New Business Development, Project Management and Business Strategy. Education: Copenhagen Business Academy – Financial Management, Danish Technical University – MSc in Industrial Engineering & Management.
Industrial Production Engineer QA, QC & PM (INS 1024)
Certified ISO 9001 & 14001 Auditor, Project Manager and Quality Management Expert. Familiar with several ISO standards e.g. ISO 13485 Medical Devices. 10+ years of experience in different Plants and Industrial Projects. A professional for implementation, coordination and automation of Quality System and Document Control. Practical application of tools (FMEA, PPAP, MSA, and SPC). Used to handle project planning, project cost and quality control. Furthermore, lead auditor for Quality and Project Audits. Consultant in QMS and HSEQ Implementation System for Factory (Piping, Electrical and Mechanical Equipment). Education: Engineering/Industrial Management & Master of Business Administration (MBA).
Regulatory Affairs, QC, QA and HSE (INS 0806)
Pharmaceutical professional with expertise in QC, QA & RA. 8 years working experience in pharmaceutical industry with leading international companies. Furthermore, working in the field of HSE (Human Safety and Environment). Reviewing Validation Protocols, Reports, Master Plans including Validation of Method, Processes and Cleaning. Reviewing Standard Operating Procedures (SOP), Deviation Report, Risk Analysis and Change Control. Performing internal self-inspection, quality audit, GMP monitoring of departments, laboratory and production. Tests of raw materials, semi-finished and finished products. Establishing standards for microbiological and physicochemical. Procurement and monitoring of laboratory equipment. Monitoring drugs stability studies and preparing reports. Responsible for preparing, compiling and submitting documentation to health authorities and managing quality activities within the RA CMC area in Regulatory Affairs. Involve in new registration including specifying storage, labelling and packaging requirements. Education: Medical Sciences, Doctor of Pharmacy