Job Title: Syringe Process Manager
Location: Swiftwater, PA
About the JobThe Syringe Process Manager is responsible for overseeing all personnel and operational activities within their assigned shift, ensuring full team adherence to QDCI standards. This role drives continuous improvement of line performance by leading and supporting strategic projects and initiatives, including thorough investigation of deviations from planned outcomes and the development of robust Corrective and Preventive Actions (CAPA) to prevent recurrence. The position requires strong leadership, shift flexibility for coverage and project completion, regulatory awareness, and a commitment to producing safe, high-quality aseptic products.
This role manages all shift-level processes to meet departmental goals and priorities while ensuring full compliance with regulatory authorities including cGMPs, CBER, WHO, EP, and other applicable regulatory bodies.
Main Responsibilities- Production Management: Lead, schedule, and plan shift operations through effective utilization of key process systems including eOOE, iObeya, Qualipso, SAP, and Ocularis to ensure consistent, compliant output 20%.
- Critical Function Leadership :Lead and execute essential operational functions including 5W2H analyses, Gembas, MSVs, LSVs, real-time reviews, BFRs, Sartocheck, Paltronic, and Ops Tracker audits to maintain operational excellence 20%.
- Process Improvement & Project Work: Identify, develop, and lead continuous improvement initiatives and cross-functional projects that enhance line performance, reduce waste, and drive measurable results 30%.
- Cross-Functional Coordination :Partner with supporting departments and lead structured meetings to align priorities, resolve issues, and achieve all +QDCI performance standards 10%.
- PCU Development & Training :Support the growth and capability of Production Control Unit (PCU) team members through structured development plans, coaching, and training delivery 10%.
- Personal Training & Development: Actively pursue professional growth through assigned training modules, certifications, and development opportunities aligned with role requirements 10%.
- Planning and initiating production schedules, coordinating personnel activities across manufacturing teams, and reviewing batch records for accuracy and completeness.
- The role carries broad accountability across employee development, counseling, cost reduction recommendations, quality assurance, incident investigations, CAPAs, and departmental budget management. Shift flexibility is required to drive project completion.
- The position serves as the primary managerial coverage for shift employees and acts as a key liaison for communicating technical issues and process improvements to relevant stakeholders (e.g., IOC, Management Committee, staff meetings). When required, this role coordinates Maintenance, Metrology, and Validation activities with functional leaders and plays an active role in implementing new equipment and procedures.
- Deviation management, people development, and Quality Assurance of the Aseptic Processing area are core to this role. A background in Aseptic Processing is strongly preferred.
Dimensions / Scope:Safety- Adheres to and enforces all safety procedures to protect self and others; participates in monthly safety meetings
- Conducts LSVs and MSVs; reports all safety incidents, concerns, and near misses to team leadership
- Actively participates in safety walkthroughs and contributes ideas for corrective and preventive actions
- Supports safety improvement initiatives and investigations
- Utilizes +QDCI boards to track and address safety issues
- Follows effective procedures to ensure production of a safe and efficacious product
Quality- Serves as a point of contact for training discussions related to regulatory and internal inspections
- Ensures all operations comply with cGMPs, CBER, WHO, EP, and other applicable regulatory bodies
- Leads and supports 5W2H and deviation meetings; develops sound CAPA to prevent recurrence
- Conducts real-time reviews to assess aseptic performance, GMP data entries, and metric accuracy
- Builds and maintains a positive working relationship with the Quality group
Delivery- Performs data review and analysis to identify and drive line performance improvement initiatives in collaboration with CI Specialists and Reliability/Asset Care Engineering
- Supports production flexibility in response to volume fluctuations and business needs
- Follows escalation procedures to mitigate variables negatively impacting eOOE
- Reviews eOOE metrics throughout the shift to ensure accurate downtime categorization
- Ensures personnel training is assigned and documented in a timely manner to support business continuity
Cost- Drives CI and cost reduction initiatives to improve operational efficiency
- Executes procedures as documented to minimize deviations and associated costs
- Implements training methodologies to improve operator efficiency
- Supports all changeover functions to achieve eOOE standards
Involvement- Completes all assigned training modules and maintains qualified trainer status
- Trains and orients new team members at all levels as assigned
- Leads and participates in team meetings with professionalism, respect, and confidentiality
- Ensures Training Coordinators and Trainers guide personnel in proper work procedures, equipment use, cGMPs, safe work techniques, and SAP for timely and consistent sign-offs
Physical Working Conditions:- Office Environment 50% of time
- Proper PPE (eyewear) 50% of time
- Isopropyl Alcohol exposure 15% of time
- Lifting (up to 25 lbs) as needed
- 3rd Shift role (Tuesday - Saturday)
About You Basic Qualifications- Bachelor's degree in Life Sciences, Engineering or Business or 7+ years of equivalent experience in manufacturing and/or filling of biological products
- Relevant manufacturing experience in an FDA-regulated industry with working knowledge of cGMP standards.
- 1+ years of relevant experience in leadership roles.
- Experience with aseptic processing is strongly preferred
Skills & CompetenciesTechnical Skills:- Intermediate proficiency in MS Office Suite
- Working knowledge of SAP (preferred)
- Familiarity with Lean Manufacturing principles (preferred)
- Mechanical and engineering competency (preferred)
- Engineering background (preferred)
Soft Skills:- Strong leadership capabilities with the ability to inspire, motivate, and develop teams in manufacturing environments.
- Excellent verbal and written communication, interpersonal, and presentation skills.
- Highly detail-oriented and organized with strong time-management capabilities.
- Strong analytical and problem-solving skills with the ability to adapt in a dynamic environment.
- Ability to interact effectively with employees at all levels of the organization.
- Maintain an unwavering commitment to product quality and patient safety in all decisions.
The salary range for this position is:
$78.000,00 - $112.666,66
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.
