Vial Filling Process Owner Manager (2nd Shift Line 6)

Scorpion Therapeutics; United States; Remote; USD 80,000 - 100,000; Full time

Job summary

A leading healthcare company seeks a Vial Filling Process Owner Manager for the 2nd shift in Swiftwater, PA. This role involves overseeing production, ensuring compliance with regulatory standards, and leading process improvements. With a focus on team development and safety, candidates should possess strong organizational and communication skills, alongside relevant experience in manufacturing. Join a supportive team offering growth opportunities and a comprehensive benefits package.

Benefits

Health benefits

Wellness programs

Parental leave

Qualifications

• Detail-oriented with strong organizational skills.
• 3-5 years in manufacturing or development, with experience in a pharmaceutical setting.

Responsibilities

• Manage production, ensuring adherence to +QDCI standards.
• Lead process improvement projects and develop team skills.

Skills

Detail-oriented

Analytical problem-solving

Excellent communication

Adaptability

Education

BSc in Life Sciences

BSc in Engineering

7+ years relevant experience

Tools

MS Office

SAP

Job description

Job Title: Vial Filling Process Owner Manager - 2nd Shift Line 6

Location

Swiftwater, PA

About The Job

We deliver 4.3 billion healthcare solutions annually, thanks to our meticulous Manufacturing & Supply teams. With your talent, we can do even more to protect against infectious diseases and support patients and their families.

Summary of Responsibilities

Oversee personnel and activities during your shift, ensuring team adherence to all +QDCI standards.

Key Accountabilities

1. Manage production through leading, scheduling, planning, and utilizing process systems like eOOE, iObeya, Qualipso, SAP, and Ocularis (20%)
2. Sustain processes via functions including 5W2H, Gembas, MSV, LSV, real-time reviews, BFR, Sartocheck, Paltronic, and Ops Tracker audits (20%)
3. Lead process improvement projects (30%)
4. Coordinate with supporting agencies and lead meetings to meet +QDCI standards (10%)
5. Develop team skills (10%)
6. Engage in personal training and development (10%)

Major Challenges

Manage shift processes to meet goals, ensure compliance with cGMPs, CBER, WHO, EP, and other regulators. Plan production schedules, review batch records, and handle employee development, cost control, quality, incident investigations, and departmental budgets. Provide managerial coverage during shifts and communicate process improvements and issues to relevant groups.

About Our Company

We are an innovative global healthcare company committed to scientific breakthroughs to improve lives. We offer growth opportunities, connections, and a chance to push your limits. Ready to join us?

Main Responsibilities

This exempt role in the Filling Department offers bi-weekly pay based on experience and education.

Safety Responsibilities

• Follow safety procedures and participate in safety meetings.
• Report safety concerns and participate in safety walkthroughs.
• Contribute ideas for safety improvements.
• Use +QDCI boards for safety issues.

Quality Responsibilities

• Understand regulatory audits and serve as a training point for inspections.
• Ensure operations comply with cGMPs, CBER, WHO, EP, and other standards.
• Support real-time reviews and maintain positive relations with quality teams.

Delivery & Cost

• Support production volume needs and staffing flexibility.
• Follow escalation procedures and review downtime metrics.
• Ensure personnel training and support cost reduction initiatives.

Involvement

• Train in all assigned modules and mentor new team members.
• Lead team meetings and uphold professionalism and confidentiality.
• Ensure proper training and maintain trainer status.

Qualifications

• Detail-oriented with strong organizational skills.
• Analytical problem-solving skills and adaptability.
• Excellent communication skills and proficiency in MS Office; SAP knowledge preferred.
• Lean manufacturing and mechanical skills are advantageous.

Education & Experience

• BSc in Life Sciences, Engineering, or related field, or 7+ years relevant experience.
• 3-5 years in manufacturing or development, with experience in a pharmaceutical setting and knowledge of cGMPs.

Why Join Us?

Join a supportive, innovative team with opportunities for growth and a comprehensive benefits package, including health, wellness, and parental leave. We are an Equal Opportunity Employer committed to diversity and inclusion.