Validation Engineer - Marcus Hook, United States - Quotient Sciences Limited

Quotient Sciences Limited Marcus Hook, United States

3 weeks ago

Description

Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway.

Cutting through silos across a range of drug development capabilities, we helpbiotech and pharma customers save precious time and money in getting drugs to patients.

As a growing and successful business, we employ more than 1,100talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA.

Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it.

People join Quotient Sciences because we are a respected member of the drug development communitythat's focused on innovation and are driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures,

fast. Because humanity needs solutions, fast.
The Role

The Validation Engineer is responsible for providing engineering support for maintenance and validation activities while managing regulatory requirements around methodology and protocols for pharmaceutical manufacturing.

Main Tasks and Responsibilities

Manages the scope, deliverables, schedule, budget, and quality of maintenance/engineering projects related to CGMP process equipment, utilities, controls, and physical building.

This may include generation/review of design documentation, participation in both factory and site acceptance testing, participation in equipment installation and facility construction activities.

Prepares and presents project status reports
Maintains engineering and validation records in both hard copy and electronic form
Identifies and mitigates risks to ensure business continuity and protect the company from loss
Manages implementation of appropriate corrective and preventative actions for existing equipment and manufacturing processes
Manages the design, specification, and installation of new/renovated process equipment and facilities modifications
Evaluates, approves, prepares, and executes change control documentation, including like for-like component assessments
Provides support and recommendations for continuous improvement initiatives utilizing lean manufacturing tools and/or other techniques
The Candidate

Knowledge:
The factual and procedural information required to perform the role
Bachelor's degree in Engineering, Information Systems, or a related field of study preferred
Experience working in a highly regulated industry (i.e., food, beverage, nuclear, pharmaceuticals etc years)
Experience working in Validation or related field including IQ,OQ,PQ development and execution and environmental mapping experience (0-5 years)
Experience working with pharmaceuticals including Oral Solid Dosage Manufacturing is highly desirable
Experience or formal training with CAD or other graphical software packages desired

Skills:
The effective use of knowledge and abilities in performance.
Proficient knowledge of Microsoft Office Suite required
Proficient knowledge of Microsoft Project, Excel, Visio, and Minitab preferred
Strong mathematical skills with the ability to apply concepts to practical solutions including the use of fractions, percentages, ratios, proportions and fundamentals of plane and solid geometry and trigonometry
Complies and adheres to Good Manufacturing Practice (GMP) standards by utilizing and maintaining safety procedures
Ability to work in a hazardous environment with high requirement to follow safety procedures

Abilities:
Innate traits or talents a person possesses
Time management skills with the ability to manage strict and tight deadlines
Multitasking skills with the ability to manage a range of tasks and issues simultaneously
Strong analytical skills with the ability to create recommendations and corrective actions based on data
Physical Demands
In this role a person must be able to complete the following:
Sit at a workstation 10% of working time

Walk or stand in the warehouse, manufacturing, or office areas while leading or assisting in the process of creating, packaging, or transporting projects or pharmaceutical batches.

90% of working time.

Bend, reach, lift, pull, operate, and physically transport production equipment, inventory, Active Pharmaceutical Ingredients, non-inventory, packaging equipment, or other equipment.

Lift up to 49.9 pounds -team lift pounds
Pull manual pallet jack up to 1,999.9 pounds
Operate PIT lifts, powered pallet jacks or forklifts 2000-5,000 pounds

Occasionally operate a computer or other office machinery (calculator, phone, copy machine, or printer)

Frequently wear PPE such as safety glasses, Tyvek suit, Respirator, and other applicable protective equipment when in contact with Active Pharmaceutical Ingredients in GMP Manufacturing environments.

Communicate information and ideas so others will understand. Must be able to exchange accurate information written and verbally.
Occasionally work outside the typical work schedule
We are an Equal Employment Opportunity ("EEO") Employer.

It has been and will continue to be a fundamental policy of Quotient Sciences not to discriminate on the basis of race, color, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws.

This policy applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.

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