Found 1025 Science/ Biotech/ Pharmaceuticals Jobs

Hi,

This is Rohini with SSI, We have an immediate opening for Quality Engineer PM Consultant III with our Direct client. If you are interested please reach me with your Updated Resume

Title: Quality Engineer PM Consultant III

Duration: 9months (will extend after that)

Location: Bothell WA 98021

Responsibilities include:

• Working in the medical industry brings much fulfilment, as well as unique challenges. As part of our HealthTech focused company, you will be responsible for successfully dealing with and managing Philips relationships with approval agencies such as the US Federal Drug Administration (FDA).
• Project manage all aspects of CAPA activity which includes gaining the commitment of cross functional resources, scheduling CAPA team meetings, and ensuring CAPA deliverables per project timelines.
• Represent CAPAs during audits and CAPA Review Board meetings.
• Lead and mentor cross functional teams with the implementation of appropriate root cause analysis techniques (eg Pride problem solving).
• Analyse quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances.
• Work effectively with all levels of management to ensure CAPA action plans can be supported and that costs/resources needed to implement the plan are available.
• Perform periodic trend analysis and corrective action effectiveness measures of all quality system events and identify opportunities for improvement.

We are looking for:

• A person who is excited by the unique professional challenges that our Quality Transformation presents, has strong technical competencies, and demonstrates resilience challenging, often demanding situations. We are looking for a perfectionist- a fixer who continuously strives for excellence as a way of life; not just as a job. We're looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life billions for the billions of people Philips brand touches each year.

Requirements:

• Able to understand and analyze complex problems, including software and hardware design issues.
• Demonstrated knowledge of tools and techniques required to perform thorough root cause analysis and develop strong investigations.
• Strong understanding of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001 and ISO 14971.
• Demonstrated ability to partner with the business and effectively interact with and influence employees, and managers on all levels.
• Strong Project Management skills, including ability to project manage all CAPA activities.
• Ability to analyze data and apply statistical techniques.
• Excellent written and verbal communication skill

Hi,

This is Rohini with SSI, We have an immediate opening for QA Engineer Consultant II with our Direct client. If you are interested please reach me with your Updated Resume

Title: QA Engineer Consultant II

Duration: 12months (will extend after that)

Location: North Maple Grove MN 55311

Description:
What You Will Do:

• You will be supporting R&D integration efforts, including the remediation of Risk Files of Legacy SPNC Products. Activities include creating of Risk Management Matrix, converting from Legacy FMEA template's to Philips FMEA templates, assess risks to new risk classifications, identify gaps is previous verification and validation activities and then address gaps as needed.

What Success Looks Like:

• Create Risk Management Matrix for Legacy products, using the PHA's, DFMEA, UFMEA and complaint history.
• Convert Legacy UFMEA, DFMEA and PFMEA into new templates, developing language that is more patient focused.
• Reassess Risk Classifications using new templates and identify where Risk Classifications have increased.
• Identify gaps in verification, validation or component qualification testing occur due to a change in Risk Classification and develop and execute a plan to close gap.
• Collaborate with Development Engineering and Design Assurance Engineering stakeholders to develop strategies and review work.
• Tracks and reports progress and will communicate any identified risks or delays to projects.

Desired Experience:

• B.S. of Mechanical, Chemical, Industrial, Materials or Biomedical Engineering or similar field
• 5 years of experience working in verification and validation of Medical Devices as a Quality Engineer or Development Engineer.
• Must have experience in applying Risk Management using a life cycle approach.
• Working knowledge of 21 CFR 820, ISO 13485, and ISO 14971.
• Experience creating FMEA's, writing test protocols and reports and developing engineering justifications.
• Experience with MS Word and MS Excel.
• Ability to travel up to 10%.

Hi,

This is Rohini with SSI, We have an immediate opening for Mechanical Engineer with our Direct client. If you are interested please reach me with your Updated Resume

Title: Mechanical Engineer

Duration: 3months (will extend after that)

Location: Bothell WA 98021

Mechanical Engineer

Experience:

• Minimum 10 years professional experience in mechanical design with extended technical know-how in electro-mechanics Switches design
• Senior Product Design level experience.
• MUST BE EXPERIENCE IN ENCODER OR ELECTRO-MECHANICS SWITCH DESIGN AND DEVELOPMENT

Education:

• Bachelor's/Master's degree in mechanical engineering

Duties:

• Mechanical design of an encoder switch component with consideration of electrical aspects in an oral cleaning device.
• Work partially in the Bothell office

Hi,

This is Rohini with SSI, We have an immediate opening for EU MDR R&D Engineer with our Direct client. If you are interested please reach me with your Updated Resume

Title: EU MDR R&D Engineer

Duration: 6months (will extend after that)

Location: San Diego CA 92130

Comments:

• The position is located in the San Diego office.
• There is 0% travel required for this position.

Update/Skills Required:

• We are looking for someone who has familiarity with EU MDR (meaning the new EU Medical Device Regulations replacing the EU MDD) and not MDR as in "Medical Device Reporting" (complaint investigation/handling).

EU MDR R&D Engineer

Description:
In this role, you have the opportunity to

• As the Medical Device Development Engineer for Philips IGT-Devices, you will apply your technical expertise to bring current and new products into Compliance with new EU Medical Device Regulations.
• This is a temporary role for 6 months and may be extended.

You are responsible for

• Coordinate with Quality/Design Assurance to evaluate post-market data
• Generating and maintaining technical drawings and detailed design documentation
• Identifying, optimizing, and implementing design/process changes on existing product and update Product DHF's to achieve compliance with Regulations (specifically, EUMDR, RoHS and REACH).
• Generating test protocols, analysing test data, and generating written reports
• Contributing to design documentation including input for the DHF and technical design reviews

You are a part of

• The R&D team within the Image Guided Therapy Devices (IGTD) business group is a team that is driven to providing products and solutions, working collaboratively within and across business groups.

To succeed in this role, you should have the following skills and experience

• Bachelors of Science in Engineering (Mechanical Engineering, Material Science, Plastics Engineering, or Biomedical Engineering preferred)
• Minimum of 5 years of Medical Device Industry experience.
• Experienced with Design Controls and Medical Device Regulations (MDD & MDR, preferably).
• Experience with creating and managing product DHF's (familiarity with electronic DHF's - ie Windchill preferred)
• Strong understanding of Design Controls (Product Requirements, Design Inputs, Design Outputs)
• Experience with Solidworks and Statistical Software applications preferred
• Knowledge of EU MDR 2017 and ISO 13485:2016 Regulations is preferred
• Understanding of RoHS and REACH Regulations is preferred
• Familiarity with cardiology catheterization procedures, tools, and terminology preferred
• Ability to work in a team environment to ensure conducive working relationships.
• Demonstrate organizational and interpersonal skills working in a cross-functional, regulated environment
• Strong analytical skills.
• Ability to organize and prioritize workflow in order to meet established time frames and schedules.
• Proficiency in Microsoft Word, Excel, PowerPoint,

Hi,

This is Rohini with SSI, We have an immediate opening for Process Engineer Consultant II with our Direct client. If you are interested please reach me with your Updated Resume

Title: Process Engineer Consultant II

Duration: 6months (will extend after that)

Location: Fremont CA 94555

Description:

• "Experience: Minimum 12 years professional experience in the applicable role. E Education: Bachelor's/Master's degree in Engineering. Experience with drug-device combination devices preferred. Expert and technical lead with proven experience. Guide and participate in test method validation, risk assessment, requirement development, protocol and validation report writing.
• Maintain, Validate and Release Test Systems in Production Environment, ideally in FDA regulated business. Firm understanding of IQ, OQ, PQ and Software Validation requirements and practices. Expertise in PFMEA, Gage R&R, test system and manufacturing software validation for medical devices within manufacturing environment.
• Ability to learn and adapt to Philips QMS and work closely with Philips Engineering community on new validation methods and re-validation projects. Guide and participate in bug testing, identification, and problem solving, oversees the validation process, the QMS system and participates in the Internal Quality Audits. Write and maintain FDA level validation protocols and reports. Support quality planning activities on new and existing programs.
• Investigate customer quality issues and requests. Interpret and implement ISO9000/13485 and FDA standards. Support internal audits. May require focus on CAPA execution in Operations."

For our client in Basel we are looking for an Engineering Technician for a 6-month contract.

Job title: Engineering Technician

Duration: 01/02/2019 to 31/07/2019

Location: Basel

Workload: 100%

Description:

Main Tasks:
. Work with team to develop medical devices used in combination products eg. auto-injector or injection pens
. Develop mechanical test methods to characterize the performance of medical devices, including fixture design and programming of test equipment
. Test medical devices and record results, following good documentation processes
. Build devices and subassemblies of medical devices following work instructions
. Perform general upkeep and housekeeping of the engineering laboratory

Professional Experience:
An ideal candidate would have at least three years of experience working in product development, preferable in an engineering or testing laboratory.

Must haves:
. Has good mechanical aptitude and is comfortable working with their hands
. Experience in testing complex devices during product development
. Experience in programming force and torque testing machines, such as Zwick or Mecmesin
. Experience in Solidworks or other similar CAD package
. Good organization and communication skills in English
. Experience in medical device development not required, but preferred

For further details please contact:
Anna Undas
(see below)

Life Science Support Coordinator - Wavre - French Speaking

An exciting new job opportunity has arisen for a seasoned Support Engineer with Life Science into join a long term project in the city of Wavre. The job is expected to be both challenging and rewarding, putting skills and abilities to the test.

Responsibility

• Support Written Standards & Training Manager on impact assessment of process changes
• Manage documentation and archival of all change requests
• Liaise with various functions, maintain trackers and reports

Skills & Experience Required

• Experience working in Life Sciences industry.
• Pharmaceutical working Experience

For successful applicants interviews are guaranteed in 24 hours and same day decisions. I have an excellent relationship with my client and can guarantee within the hour response if you contact me. So to be considered for this job in stunning Belgium, with easy access to most of Europe, contact me now for a confidential chat.

Senior Scientist wanted for our Basel based client in the pharmaceutical sector.

Your experience/skills:

• 3 years of relevant experience as a technician or engineer in GMP or non-GMP manufacturing
• Know-how in planning and performing pilot plant processes for the preparation and delivery of drug substances
• Competency of Downstream Process such as column packing, chromatography steps and filtrations
• Ability to maintain lab instruments and infrastructure as well as coordinating team activities related to non-GMP manufacturing campaigns
• Languages: fluent German both written and spoken, basic knowledge of English

Your tasks:

• Keeping record of and managing chemicals, intermediates, excipients and solvents
• Collaborating with other team members to facilitate deliveries of drug substances
• Providing raw data documentation, evaluation and result interpretation as well as proposing input for the design of next experiments
• Supporting transfer procedures and instructions to pilot plant or production, including troubleshooting and process steering controls
• Seeking proactively for support and coaching from project leader, scientific experts or other team members during the whole process

Start: 01/2019

Duration: 12MM

Location: Basel, Switzerland

Ref.Nr.: BH13849

Does this sound like an interesting and challenging opportunity to you?

Then take the next step by sending us your CV as a Word document and a contact telephone number.

Due to work permit restrictions we can unfortunately only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.

Going the extra mile

New to Switzerland?

In case of successful placement, we support you with:

• All administrative questions
• Finding an apartment
• Health - and social insurance
• Work permit and much more

Senior Scientist wanted for our Basel based client in the pharmaceutical sector.

Your experience/skills:

• 3 years of relevant experience as a technician or engineer in GMP or non-GMP manufacturing
• Know-how in planning and performing pilot plant processes for the preparation and delivery of drug substances
• Competency of Downstream Process such as column packing, chromatography steps and filtrations
• Ability to maintain lab instruments and infrastructure as well as coordinating team activities related to non-GMP manufacturing campaigns
• Languages: fluent German both written and spoken, basic knowledge of English

Your tasks:

• Keeping record of and managing chemicals, intermediates, excipients and solvents
• Collaborating with other team members to facilitate deliveries of drug substances
• Providing raw data documentation, evaluation and result interpretation as well as proposing input for the design of next experiments
• Supporting transfer procedures and instructions to pilot plant or production, including troubleshooting and process steering controls
• Seeking proactively for support and coaching from project leader, scientific experts or other team members during the whole process

Start: 01/2019

Duration: 12MM

Location: Basel, Switzerland

Ref.Nr.: BH13849

Does this sound like an interesting and challenging opportunity to you?

Then take the next step by sending us your CV as a Word document and a contact telephone number.

Due to work permit restrictions we can unfortunately only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.

Going the extra mile

New to Switzerland?

In case of successful placement, we support you with:

• All administrative questions
• Finding an apartment
• Health - and social insurance
• Work permit and much more