Steriles Packaging Engineering Specialist

Work Schedule

Environmental Conditions

Job Description

Join us as a Scientist!

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.

Essential Qualifications:
•    Bachelor’s degree in Packaging Engineering, Packaging Science, Chemistry, Life Science, with 2-4 years’ experience in parenteral package development, primarily in pharmaceutical industry
•    Analytical and/or lab based experience in the pharmaceutical industry

Preferred Qualifications:
•    Knowledge of parenteral packaging materials, components, vendors, analytical equipment, and technologies.
•    Experience in sterile drug primary packaging development for large and small molecules including vial/stopper, pre-filled syringes, and cartridges presentations.
•    Knowledge of domestic and international packaging requirements and regulations (i.e., current applicable FDA/MAA guidelines, USP/Ph Eur, etc).
•    Knowledge of statistical analysis and Design of Experiments as they apply to packaging operations.
•    Ability to quickly establish relationships with internal and external stakeholders. 
•    Strong time management / organizational skills. 
•    Evidence of team working skills and flexibility.

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Work Summary:

To provide packaging development analytical support in the UP, PA site.
The task list outlined below provides a comprehensive summary of the crucial work that needs to be carried out in the Steriles Packaging Development lab/team. This work is primarily aimed at offering support for a multitude of projects related to Steriles ViiV projects in development.

Tasks:
•    Perform timely execution of lab based analysis, including experiment write up to support sterile primary package selection, integrity, stability, and lifecycle for the coordination and testing of samples
o    Examples of analytical technique include extrusion force testing, stopper movement assessment, CCI capabilities including HeLD, Vacuum Decay, and headspace analysis
•    Be a practical expert in a packaging/analytical technique relevant to a primary pack presentation, capable of training others in the technique and application
•    Collaborate with the Lab Manager to maintain the License To Operate (LTO) status in the Lab – including equipment maintenance, documentation and coordination with vendors, management monitoring, and safety requirements
•    Maintain packaging lab component and lab inventory, including ordering, receiving, and organization of lab space to enable dynamic, flexible laboratory workspace
•    Prepare and communicate data summaries to relevant project team members

Stretch Tasks:
•    Writing work instructions, study protocol contribution
•    Authoring/revising component specifications
•    Supporting document and knowledge management 

Working Conditions and Environment:
• Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment.
• Occasional drives to site locations, occasional domestic travel.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste.
• Personal protective equipment required such as protective eyewear, garments and gloves.
• Exposure to fluctuating and/or extreme temperatures on rare occasions.

Physical Requirements:
• Ability to work in an upright and /or stationary position for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment.
• Occasional mobility needed.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Frequently interacts with others to obtain or relate information to diverse groups.
• Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
• Regular and consistent attendance.

Why Join Us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience – and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthrough.