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Temporary Validation Engineer

3 months ago

Vista, United States BIO FILM INC Full time
Job DescriptionJob DescriptionDescription:

How would you like to work for an innovative, forward-thinking company that manufactures and distributes high quality healthcare products for the world? If you are passionate about teamwork, are driven by exceeding expectations in all that you do and thrive in an organization that promotes having fun while making a difference, join us


As a privately held company since 1991, we at BioFilm, research, develop, and manufacture the best healthcare products to enhance intimate activities, quality of life and protective wellness. In beautiful Vista, California, our facility is the hub

You’ll work with leading researchers, engineers and scientists in a culture that embraces ingenuity.


What we offer:

4-day work weeks – every Friday off

Alternative Work Week: BioFilm works an alternative work schedule of four 9.5-hour days. You will be likely assigned to one of the following schedules, 6:00 am – 4:30 pm -or- 7:00 am – 5:30 pm, with one hour for lunch.


As the Temporary Validation Engineer...

Please note- This position is Temporary for 6 months.

Purpose of Position

The Validation Engineer is responsible for: planning, executing, and documenting validation activities to ensure that systems, processes, products, or equipment meet quality, safety, and regulatory standards; implementing validation expertise to meet validation objectives; developing validation plans that outline the scope, objectives, resources, and timelines for validation activities.

Key Roles of Accountability

  1. DESIGN TESTING PROCEDURES, PROTOCOLS AND ACCEPTANCE CRITERIA FOR VALIDATION PURPOSES IN A MEDICAL DEVICE ENVIRONMENT
  2. CREATE, EXECUTE, AND REPORT ON VALIDATION PROTOCOLS INCLUDING IQ, OQ, PQS.
  3. ASSIST WITH TESTING, VERIFICATION, AND DOCUMENTATION OF COMPUTER SYSTEMS AND CELATED EQUIPMENT
  4. IDENTIFY POTENTIAL RISKS AND QUALITY ISSUES, AND WORK TO MITIGATE THEM THROUGH VALIDATION ACTIVITIES.
  5. PROVIDE ENGINEERING AND VALIDATION EXPERTISE TO PROJECT TEAMS DEVELOPING NEW PROCESSES
  6. STAY UPDATED ON INDUSTRY BEST PRACTICES AND REGULATORY CHANGES AND PROPOSE PROCESS IMPROVEMENTS TO ENHANCE THE VALIDATION PROCESS.


ESSENTIAL DUTIES AND RESPONSIBILITIES

Engineering

  • Develops validation plans that outline the scope, objectives, resources, and timelines for validation activities including defining acceptance criteria and testing protocols.
  • Writes, reviews, and approves validation protocols including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Validation protocols, as applicable.
  • Conducts validation testing, including equipment setup, execution of test cases, and data collection. Ensures that all testing is performed according to approved protocols.
  • Analyzes validation test data to determine if systems, processes, or products meet pre-established acceptance criteria. Identifies and document any deviations or discrepancies.
  • Interacts with project and development personnel to ensure that processes and designs are compatible with software capabilities and validation requirements to ensure proper scale ups can occur.
  • Constructs and executes controlled experiments (including DOE's) within scope of verification and validation activities including IQ, OQ, and PQ.
  • Maintain detailed records and documentation of all validation activities. Prepare validation reports summarizing the results, conclusions, and any necessary actions.
  • Ensures assigned projects/processes comply with FDA, Quality System Requirement (QSR), ISO-13485 and other applicable requirements.
  • Trains end users of software and validated equipment within the scope of executing validation protocols.


Collaboration

  • Maintain cooperative, diplomatic working relationships with co-workers, supervisor, and the public.
  • Works as part of the team and collaborate with co-workers and colleagues.
  • Responsible for working in compliance with medical device Quality System, ISO 13485 Regulations, safety, and all other applicable company policies.


Safety

  • Responsible for maintaining a clean and safe work environment by identifying all safety hazards and recommending corrective actions when necessary.




Requirements:

QUALIFICATIONS AND EDUCATION REQUIREMENTS:

  • Bachelors Degree in technical field. (e.g., chemical engineering, mechanical engineering, biomedical engineering).
  • Experience with ERP systems and integration with scanners, warehouse management software, preferred.
  • Knowledge of barcode creation, formatting and scanning, preferred.
  • Minimum 5 years (8+ years preferred) of experience in an engineering function dealing with validating processes and equipment in a medical device environment.
  • Strong analytical and problem-solving skills.
  • Excellent attention to detail and documentation skills.
  • Proven technical writing experience including process documentation, protocols and reporting.
  • Proficiency in statistical analysis and data interpretation.
  • Able to recognize and resolve problems quickly using sound judgment and diplomacy.
  • Previous experience in the areas of Design for Manufacturing DFM, Design of Experiments DOE and product/process Failure Mode and Effects Analysis FMEA (Preferred)
  • Experience in process improvement, Quality Control and lean/six sigma application (Preferred).

LANGUAGE SKILLS:

  • ABILITY TO READ, WRITE AND SPEAK FLUENT ENGLISH.

OTHER SKILLS AND ABILITIES:

  • Ability to scope and manage projects involving external contractors and internal cross functional team members
  • A proven self-starter with the ability to identify requirements and act accordingly to produce objective results.
  • Excellent communication, organizational, and time management skills; ability to pay close attention to detail. Ability to work as part of a team and drive completion of action items.
  • Flexibility to change direction frequently and with little notice.
  • Ability to manage multiple priorities and tasks and projects.
  • Demonstrated experience developing creative solutions to both technical and non-technical problems.

COMPUTER SKILLS

  • Computer literate in a Windows Environment; Excel, Word, Power Point, Statistical Software

COMMUNICATION SKILLS

  • Strong written and verbal communication skills.
  • Strong interpersonal skills with the ability to use tact and diplomacy.

PHYSICAL DEMANDS:

  • Ability to lift up to 30 pounds.
  • Able to stand, stoop and bend.
  • Good visual color perception.
  • Able to sit at desk and use/view computer for prolonged periods of time
  • WORK ENVIRONMENT:
  • Fast paced with multi-level distractions.
  • Non-smoking.
  • Professional, yet casual work environment.
  • Office and manufacturing floor environment.
  • Ability to work extended hours as needed.
  • Ability to travel as needed.

SPECIAL CONDITIONS:

  • ABILITY TO WORK OVERTIME AS NEEDED.