Job Description
Shifts:
Training Shifts
After Training Shifts (24/7/365 Operations)
Job Purpose:
Key Responsibilities:
Education, Knowledge, Experience Required:
Education
Job Related Experience
Compliance & Documentation
Communication & Teamwork
Technology Tools
Physical Requirements
Training Shifts
- First 6 Weeks
- Monday Friday (8:00 5:00 PM)
After Training Shifts (24/7/365 Operations)
- Day Shift: 6:00 AM EST 6:30 PM EST
- Night Shift: 6:00 PM EST 6:30 AM EST
- Weekend: Rotating Biweekly Schedule
- One Week 2 Days On, 2 Days Off, 3 Days On
- Other Week 2 Days Off, 2 Days On, 3 Days Off
Job Purpose:
- The Rockville Biopharm site exists to produce and deliver biopharmaceutical drug substance of the highest quality in a safe, compliant, reliable, and cost-effective manner for their patients. The vison is to be wholly entrusted to make innovative, high-quality medicines by leveraging the best talent & technology, on a platform of continuous improvement to supply every patient, every time.
Key Responsibilities:
- Preparation, cleaning, sterilization, batching, pasteurization, or filtration & delivery of media and solutions for cell culture & purification operations.
- Perform the set-up, operation, cleaning, and break down of process equipment.
- Perform sampling procedures on various analytical instruments to analyze cell culture, solution, and/or product concentration characteristics.
- Operate Filter integrity equipment to confirm the integrity of filters pre & post use.
- Perform process operations, equipment, and instrument monitoring & trending to enable proactive identification of issues to escalate and correct with applicable departments.
- Set-up fixed & mobile process equipment and parts with CIP (Clean In Place) skids to carry out validated cleaning & sterilization processes.
- Follow appropriate standard operating procedures (SOP s), protocols, and batch records/logbooks to safely perform operations & document compliantly with good documentation and data integrity practices.
- Follow all related safety policies and procedures and put safety first by playing an active role in identifying and correcting unsafe behaviors and conditions.
Education, Knowledge, Experience Required:
Education
- Minimum Level of Education Required - High School Diploma or Equivalency
- Preferred Level of Education - Bachelor of Science/Art/associate s degree in Biological Sciences, Chemical Sciences, Engineering, or equivalent technical discipline.
Job Related Experience
- Minimum Level of Experience - 0-1 years of directly related Manufacturing experience in the pharmaceutical or biotechnology industry.
Compliance & Documentation
- Ability to follow detailed instructions and document accurately
- Practices good documentation and data integrity standards
- Adheres to safety procedures and promotes a strong safety culture
Communication & Teamwork
- Proficient in speaking, reading, writing, and understanding English.
- Strong verbal & written communication skills
- Demonstrated ability to work effectively in a team
- Willing & able to work 24/7 rotating shifts
Technology Tools
- General proficiency with Microsoft Office (Excel, Word, Outlook)
- Basic knowledge of ERP Systems (M-ERP) per global/local procedures
- Familiar with automation systems & emerging digital platforms.
Physical Requirements
- Able to lift & carry materials up to 50 lbs.
Numbers & Facts
| Location | Rockville, MD |
| Industry | Staffing/Employment Agencies |
| Salary | $23–$25 Per Hour |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | http://www.lancesoft.com/ |
About Company
We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.
Skills
- Automation Systemsunmatched
- Biologyunmatched
- Biotech and Pharmaceuticalunmatched
- CIP (Clean-in-Place)unmatched
- Cell Analysisunmatched
- Cell Culturesunmatched
- Chemical Engineeringunmatched
- Communication Skillsunmatched
- Continuous Improvementunmatched
- Data Qualityunmatched
- Documentationunmatched
- ERP (Enterprise Resource Planning)unmatched
- English Languageunmatched
- Financial Trend Analysisunmatched
- High School Diplomaunmatched
- Identify Issuesunmatched
- Lift/Move 50 Poundsunmatched
- Manufacturingunmatched
- Medical Productsunmatched
- Microsoft Excelunmatched
- Microsoft Officeunmatched
- Microsoft Outlookunmatched
- Microsoft Wordunmatched
- Mobile Plant/Equipmentunmatched
- Operations Processesunmatched
- Presentation/Verbal Skillsunmatched
- Safety Processunmatched
- Standard Operating Procedures (SOP)unmatched
- Sterilizationunmatched
- Team Playerunmatched
- Writing Skillsunmatched
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