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Position Title: Viral Downstream III 2nd shift
Work Location: Swiftwater PA 18370
Assignment Duration: 12 Months
Work Arrangement: Onsite
Position Summary:
• We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.
• Your job, as a Production Technician - Vaccine within our Biologics Team, will have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.
• This is a 2nd shift position. Must be able to work weekends and holidays as needed. This position is to become part of the Production team. This position contributes as a member of a cross-functional team to support the startup of the cGMP manufacturing facility for Flublok /Panblok drug substance in Swiftwater PA and will later continue to support the cGMP commercial manufacturing of drug substances requiring a high degree of relationship building, communication, technical knowledge, and leadership.
• The Organization is seeking a motivated professional candidate to operate within Biologics production and perform manufacturing activities. This is an exciting opportunity for a candidate to develop technical skills and learn about the biopharmaceutical industry. The production technician will operate in a cGMP manufacturing area performing equipment set up and operations tasks to meet all standards for safety, quality, and efficiency. The candidate will perform production in accordance with volume fluctuation, business need, and effective procedures.
• This position may be required to be moved or temporarily flexed to another department or building within the Biologics operations due to business needs. Additionally, candidates should expect to work in multiple buildings. Some overtime/off shift work hours may be required based on business needs.
Key Responsibilities:
• Ensuring that processes are always compliant with FDA regulations.
• Works to become trained in all assigned training modules.
• Identifying and preventing deviations and assisting in investigation and root cause analysis.
• Helping with deviation investigations, Corrective and Preventive Actions (CAPA), Change Control Requests (CCR) and other assigned projects.
• Ensuring that quality documents like Electronic Batch Records (eBRs) and electronic logbooks are completed accurately and on time.
• Ensuring documentation is completed accurately and in real-time is crucial for compliance and quality control.
• Preparing areas for the next shift helping to maintain smooth operations and efficiency.
• Responsibly use material in an efficient matter to reduce waste.
• Sharing improvement ideas, issues, concerns to team members along with providing solutions.
• Proactive in identifying and solving production issues to ensure smooth operations.
• Follow all procedures put into effect to ensure your safety as well as the safety of others. Participate in monthly safety meetings.
• Report all safety issues, concerns, incidents, and near misses to the team leadership promptly.
• Actively participate in safety walkthroughs coordinated by the department’s safety team.
• Provide input on potential safety issues and contribute ideas for the corrective and preventative actions.
Qualification & Experience:
• High School Diploma plus one-year experience in a cGMP environment or pharmaceutical experience.
• Associate Degree and Bachelor’s degree with 0-year experience.
• Good mechanical skills, computer skills and is detail oriented.
• Must have basic mechanical aptitude, computer skills, good comprehension skills, retention skills, troubleshooting and manual dexterity.
• Proficiency in at least but not limited to one area of operation or product line.
• Ability to lift up to 50 lbs.
• Ability to stand on average 8 hours per shift.
• Ability to gown and gain entry to manufacturing areas.
• Ability to be flexible with work schedule. Potentially modified shifts for training and business needs including holidays and weekend.
• May require personnel to flex into another platform within MTech and/or another M&S department, as well as the possibility to work weekends, holidays or off shift hours based on business need.
• May also include working in an aseptic processing area.
• Fit testing requirements of N95 may be required depending on the area you are assigned.
• For aseptic area production roles candidate must be able to obtain and maintain current aseptic gowning qualification.
• Able to stand for up to 8 hours a day (with occasional breaks).