Location
Philadelphia, PA | United States
Job description
Are you ready to join a growing, global drug development and manufacturing organization that puts people first? Come to Adare! We work closely with our pharmaceutical industry partners during all phases of drug development and commercial manufacturing with a mission of improving the lives of patients and medicines essential to people all over the world. Every role within Adare offers you a unique, customized experience with a chance to make a real impact that is critical to our success. With the help of people like you dedicated to our mission, Adare is transforming lives by transforming drug delivery!
Join our mission at Adare !
What can Adare offer you?
- Medical/dental/vision/life – low employee premium
- 401k with a highly competitive match
- Generous PTO, including floating holidays
- Career growth and internal opportunities
- Tuition reimbursement
- Relocation assistance
- Performance-based bonus
- Employee Recognition Programs
We are seeking to hire a Validation Scientist to join our Technical Services team…
If any of the below describes you, we would love to meet you!
JOB SUMMARY
The Validation Scientist is a key member of the Technical Services team in Philadelphia and will perform Validation activities with a concentration on packaging validation, which includes process and cleaning validation, adhering to cGMP policies/procedures and Adare’s quality standards. The Validation Scientist will also design and write Manufacturing/Packaging Batch Records, Protocols, Prepare Risk Analysis and FMEA (Failure Mode Effect Analysis), Execution, and write reports as necessary.
RESPONSIBILITIES AND LEARNING OPPORTUNITIES
- Responsible for driving all aspects of project and material planning
- Execution of validation batches, creating batch manufacturing/packaging record, risk analysis and FMEA creation and follow up through approval of documents.
- Evaluation of validation study data and providing primary conclusion
- Author, review, revise, or approve Standard Operating Procedures (SOP’s) or other documents as required
- Interface with Manufacturing, Packaging, and Engineering to facilitate and drive document review and approval
- Monitors Technicians, Operations and Quality personnel during validation activities, as necessary.
- Provide support for scale-up, technology transfer and commercial projects
- Follow cGMPs, safety procedures, DEA procedures, department SOPs and company policies
- Participate on cross-functional team that address specific problems, facilitate discussion and research, enabling procedures to become more efficient, and to build and enhance interdepartmental relationships.
- Perform investigations on deviations and trouble shoot when required
- Prepare protocols, manufacturing batch records, ensure sampling and testing are completed as planned, executing manufacturing batch records and evaluate all in-process and analytical data and write reports.
- Coordinate cleaning and manufacturing activities with company Quality Units, Operations, R&D, etc for validation projects.
- Review, as necessary, all pertinent documentation, cleaning procedures, batch history and technical transfer reports prior to validation and/or scale up activities.
- Attend team meetings, act as Process Validation representative as required.
- Must participate and successfully complete all training as required by the company.
- Perform other duties as assigned.
Requirements
- B.S. in Pharmacy or Bachelor degree in relevant science/engineering discipline, Masters in pharmaceutical engineering is plus
- 3+ years’ experience working in the Life Science industry with 1+ year(s) experience in Validation
- Technical understanding and hands on experience of pharmaceutical unit operations
- Proficiency with Quality by Design (QbD) concepts, statistical process control (SPC) and complex data analysis
- Hands on experience using statistical data analysis tools
- Computer skills and Microsoft Word, Excel, PowerPoint
- Good planning and coordination skills and able to adapt to changes in priorities and project schedules
- Quality and attention to detail in documentation work and reports
- Clearly present data in team meetings
- Good knowledge of cGMP requirements and current industry practices
- Ability to effectively present information
- Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of trigonometry.
- Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Benefits
- Medical/dental/vision/life – low employee premium
- 401k with a highly competitive match
- Generous PTO, including floating holidays
- Career growth and internal opportunities
- Tuition reimbursement
- Relocation assistance
- Performance-based bonus
- Employee Recognition Programs
Adare Pharma is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status
PRINCIPALS ONLY
NO AGENCIES OR THIRD PARTIES.
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