Validation Engineer at Quotient Sciences US
Boothwyn, PA 19061
About the Job
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 help biotech and pharma customers save precious time and money in getting drugs to patients.
As a growing and successful business, we employ more than 1,100 talented 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 community that’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.) (0-5 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 project management skills required
- 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 50-99.9 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.