Job Title: Syringe Filling PCU Lead
Location: Swiftwater, PA
Main Responsibilities:Provide the leadership, direction, and oversight of the Line 7 Syringe Filling PCU for B57 Aseptic filling at the Swiftwater site. This position is responsible the 24-hour performance (across all shifts) of the operating unit and team, including safety, quality, supply, and financial results. He or she provides guidance and is responsible for development of a team of managers that have the same focus area.
Team will meet the established strategic vision of FFIP Areas in B57. This Deputy Director is responsible to ensure the manufacturing facilities and equipment within his/her control is properly maintained. The PCU Lead manages ~35-45 team members across 3 shifts. In addition, this position will verify the continued validated state of all equipment and processes within their assigned area of responsibility.
- Provide leadership and direction to Line 7 Syringe Filling Process Centric Unit (PCU)
- Provide leadership and direction to ensure Deviations, Change Controls, CAPAs, and regulatory commitments are met on time and with the highest standards of quality. Responsible for ensuring assigned areas meet current FDA, International Regulatory Body, and Corporate Quality requirements. Leads audits from an operation side for facilities and process audits
- Provide direction and oversight for the shop floor and is accountable to ensure the highest safety and quality standards are maintained. Work closely with QA and Maintenance to ensure all issues are addressed real time. Develop effective cross functional relationships to support PCU goals and activities.
- Actively pursues the implementation of best industry practices on Aseptic Processing and implementation of SMS 2.0 processes/ ways of working to drive performance and to increase Filling OEE, improve unit operations success rate and reduce operational costs under the influence of Line 7. Actively Participates and guides Asset Care/CI /Deviation meetings to ensure compliance with SMS standards. Identify and ensure all required metrics and cycle times are maintained.
- Responsible for special projects including providing assistance and recommendations regarding buildings, equipment, and processes relating to the integration of the manufacturing area. Development of working relationships and strong communication links through all levels of the organization. Provides day-to-day support for the production floor to support completion of short-term projects.
- Provides leadership and establishes departmental objectives to align with site vision for safety, quality, productivity, cost, continuous improvement, and employee involvement. Responsible for ensuring that all associates have what they need to complete their jobs safely.
- Builds and maintains a high performing team, providing effective alignment and communication with functional groups at the site and at other manufacturing sites, to successfully deliver on all commitments. Provide direction, evaluate and develop performance of direct reports
- Help in resolution of problems or introduction of changes in their respective areas
- Set performance standards and evaluate performance
- Provide career development and training advice and set short term and long-term goals Provide regular feedback to direct reports on company and departmental operations
- Manages headcount and expenses in department to achieve site objectives and meet budget expectations.
About YouBasic QualificationsEducation/experience- Minimum: High School Diploma with 7+ years' experience in a cGMP Aseptic manufacturing environment and 3+ years of experience leading teams.
- Preferred: Bachelor's degree in business, Engineering, Life Sciences or related Fields with 3+ years' experience in a cGMP Aseptic manufacturing environment and 1+ years of experience leading teams.
- Strong understanding of Quality systems
- Strong knowledge of cGMP and regulatory requirements
- Experience working in controlled/pharmaceutical industry.
Soft skills- Leadership
- Communication
- Decision making
- Conflict Management/Resolution
- Employee/Team Development
Technical skills:
- Business Analysis
- Scheduling/Planning
- Budget/Headcount Management
- Process Improvement
Preferred Qualifications- Experience in managing multiple priorities in production environment and provide support to meet the manufacturing schedule while maintaining quality and compliance.
- Experience in inspections conducted by external regulators.
- Experience working with cross-functional teams, including Quality, Manufacturing excellence, MSAT, Facilities, Engineering and Validation.
- Experience reviewing standard operating procedures, on-the-job-trainings, and other controlled documents.
- Experience troubleshooting, investigation (GPS), root cause and risk analysis in a cGMP environment.
- Ability to effectively and appropriately escalate operational issues.
Special Working Conditions- Ability to gown for entry to Aseptic manufacturing areas.
North America Applicants Only
The salary range for this position is:
$133.500,00 - $192.833,33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
