Ref No.

VE - 2018

Location

US ~ Boothwyn, PA

Validation Engineer

COMPANY OVERVIEW

Our growing and successful business comprises of over 700 talented individuals globally, in an environment where everybody counts and is instrumental to our success.  With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.

People join Quotient Sciences because we are a respected member of the drug development world, specializing in delivering innovative solutions that integrate formulation development, real-time GMP manufacturing, and clinical testing. We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.

 

GENERAL PURPOSE OF JOB

Under minimal supervision, will write, review and execute IQ/OQ/PQ protocols.  Will also aid in the monitoring and periodical testing of utilities including HVAC, CCA, Nitrogen and deionized water systems

 

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

Write IQ/OQ/PQ protocols for GMP equipment, Lab equipment and utilities.

Execute IQ/OQ/PQ protocols for GMP equipment, Lab equipment and utilities and write corresponding Summary Reports.

Review written and executed IQ/OQ/PQ protocols for GMP equipment, Lab equipment and utilities.

Support equipment and utility revalidation evaluations.

 

ADDITIONAL POSITION REQUIREMENTS

Assist other employees with writing and executing IQ/OQ/PQ protocols.

Review and sign Equipment Cleanliness Sheets.

Carries out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA.Complies with all company and site policies and procedures.

Remains current in profession and industry trends.

Makes a positive contribution as demonstrated by:

making suggestions for improvement

learning new skills, procedures and processes

Is available for other duties as required.

Is available for overtime as needed.

 

SUPERVISORY RESPONSIBILITIES

Supervise direct report of Validation Engineers and any consultants/contractors as required.

 

QUALIFICATIONS 

EDUCATION and/or EXPERIENCE

BS Degree in Engineering and one to three years Validation experience in a cGMP/cGLP regulated environment; or equivalent combination of experience, education and training.

 

LANGUAGE SKILLS

Read and interpret documents such as safety rules, operating and maintenance, instructions, and standard operating procedure manuals.

Write protocols, business correspondence and standard operating procedures manuals.

 

MATHEMATICAL SKILLS

Work with and understand engineering principles.

Apply engineering concepts to testing procedures.

Follow SOPs governing rounding and use of significant figures in data reporting.

 

 

REASONING ABILITY

Define problems, collect data, establish facts and draw valid conclusions.

Must be able to develop appropriate test procedures from reading the equipment manuals and talking to equipment operators and vendors.

 

OTHER SKILLS, ABILITIES OR QUALIFICATIONS

Knowledge of Pharmaceutical Validation requirements and concepts.

Familiarity with the solid dosage form equipment.

Familiar with a variety of laboratory equipment, such as GC, HPLC, KF, etc.

Successfully completes regulatory and job training requirements.

Computer skills:

Enter data into computer using software applications for data entry and word processing.

Work and be proficient with e-mail systems.

Ability to prioritize tasks, perform multiple job functions and pay attention to detail.

Ability to perform under stress in cases of emergency, critical or hazardous situations.

Ability to work with others in a team environment.

 

PHYSICAL DEMANDS 

While performing the duties of this job, the employee is frequently required to stand, walk, use hands to finger, handle or feel, and talk or hear.

The employee is occasionally required to sit, reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl.

The employee must occasionally lift and/or move up to 50 pounds.

Specific vision abilities required by this job include close vision, color vision and ability to adjust focus.

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