Validation Engineer Reliability Engineer- Life Sciences

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JOB SUMMARY

We are currently seeking a Validation

Engineer – Laboratory to be responsible for conducting and reporting analytical

studies to support cleaning validation and cleaning verification and to support

soil characterization studies for major GMP clinical and commercial equipment

and facilities.

Execute

analytical studies to analyze total organic carbon (TOC) and conductivity

samples.

Execute

analytical procedures to determine relative cleanability and recovery

percentages for various buffers, process intermediates, and final product

samples.

Responsible

for various functions to keep the lab operating in a GMP state, including

ownership of applicable SOPs, coordinating calibration activities, detailing

all testing activities in the appropriate electronic notebook, and performing

reviews of notebooks performed by other engineers working in the laboratory.

This position is on a client account within the pharmaceutical industry.

RESPONSIBILITIES

Responsible

for executing analytical methods to meet required timelines to support cleaning

validation and cleaning verification testing conducted in support of GMP

clinical manufacturing for a pilot plant.

Responsible

for executing analytical methods to analyze new materials that are introduced

into the global supply network, including buffers, process intermediates, and

final product samples.

This soil

characterization testing is performed in support of clinical and commercial

sites across the client account’s global network.

Deliverables

include performing the analytical testing in a timely and efficient manner to

support various project timelines; performing all work with good documentation

practices (GDP), ensuring that all laboratory equipment remains in proper GMP

state including coordinating calibration work, coordinating maintenance

activities, authoring periodic updates to laboratory SOPs, maintaining supply

inventory, etc.

Practice

highest regard for Safety.

Act

as Subject Matter Expert (SME) for the analytical methods employed by the

laboratory.

Possess

ability to answer analytical questions and interact with various regulatory

agencies.

SUPERVISORY RESPONSIBILITIES

No formal supervisory responsibilities in this position. May provide informal assistance such as technical guidance and/or training to coworkers. May coordinate work and assign tasks.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

B.S.

/ B.A. in Engineering or Science.

1

to 3 years relevant experience in GMP laboratory or

pharmaceutical validation discipline.

Strong

interpersonal skills and problem-solving ability.

Demonstrated

leadership and teamwork skills, excellent analytical abilities, excellent

written and

verbal communication skills.

Proven

record of providing excellent internal and external customer service.

CERTIFICATES and/or LICENSES

None.

COMMUNICATION SKILLS

Excellent written and verbal communication skills. Strong organizational and analytical skills. Ability to provide efficient, timely, reliable and courteous service to customers. Ability to effectively present information.

FINANCIAL KNOWLEDGE

Requires knowledge of financial terms and principles. Ability to calculate intermediate figures such as percentages, discounts, and/or commissions. Conducts basic financial analysis.

REASONING ABILITY

Ability to comprehend, analyze, and interpret documents. Ability to solve problems involving several options in situations. Requires intermediate analytical and quantitative skills.

OTHER SKILLS and ABILITIES

Must possess a thorough knowledge of the use, setup and operation of Windows-based computers and desktop applications such as MS-Word and MS-Excel.

SCOPE OF RESPONSIBILITY

Decisions made with understanding of procedures and company policies to achieve set results and deadlines. Responsible for setting own project deadlines. Errors in judgment may cause short-term impact to co-workers and supervisor.

SAFETY

Responsible for personal safety and the safety of those who are affected by your work. This includes but is not limited to: Complete all required and assigned HSE training at a satisfactory level,Follow all activity policies and procedures, including all HSE-related requirements at all times,Participate in all HSE-related programs & activities as required, including incident investigations, interviews, auditing and assessment, etc.Report any conditions which you feel could result in an accident or injury and / or stop work if required.

US Company Profile

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Company info

Inspection & Valuation International, Inc.
Website : http://www.ivi-intl.com/