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Backup Section Leader - MFG

DifGen Pharmaceuticals

Tamarac (FL)

On-site

USD 90,000 - 110,000

Full time

2 days ago

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Job summary

DifGen Pharmaceuticals is seeking a Backup Section Leader - MFG to ensure continuous manufacturing operations and compliance with GMP standards. This role requires strong leadership and manufacturing expertise to train staff, resolve issues, and meet production goals, contributing to critical drug delivery technologies in a dynamic pharmaceutical environment.

Qualifications

4+ years of experience in a fast-paced, Lean Manufacturing environment required.
3+ years experience in aseptic environments, sterile filling, or aseptic technique preferred.
Must be fluent in reading, writing, and speaking English.

Responsibilities

Ensure continuous operations in accordance with Batch Record manufacturing instructions.
Respond to and resolve process and equipment problems independently.
Train new employees on processes and ensure compliance with GMP standards.

Skills

Leadership

Coaching

Manufacturing expertise

Safety measures knowledge

Time management

Organizational skills

Problem-solving techniques

Education

General education degree (GED)

Master's degree preferable

Tools

SAP

MS Word

MS Excel

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About Us

Aveva Drug Delivery Systems is a pharmaceutical manufacturer at the forefront of innovative drug delivery technologies. We are dedicated to advancing solutions that optimize the efficacy, safety, and precision of pharmaceutical treatments. Join our team and help shape the future of healthcare by contributing to the development of groundbreaking drug delivery systems that improve patient outcomes worldwide.

Uses qualifications to perform process steps whenever necessary to support continuous operations, in accordance with Batch Record manufacturing instructions and current labor standards in order to safely and efficiently manufacture a quality product.
When necessary for continuous operations, assembles, disassembles, and cleans equipment used for manufacturing in accordance with the applicable GMP procedure to ensure proper operation and cleanliness of the equipment.
Performs daily review of batch documentation for accuracy and completeness. At the end of the batch reviews all batch documentation for accuracy and completeness prior to submitting batch for review.
Ensures Operators monitor and document the critical process parameters during the manufacturing process.
Responds to and resolves process & equipment problems independently. Notifies Supervisors and works with other departments (Quality Assurance, Engineering, Technical Services, R&D, etc.) to facilitate resolution of issues.
Works with Quality Assurance and Engineering to ensure the manufacturing process meets quality specifications.
Acts as Subject Matter Expert on production procedures to support investigations, CAPAs, projects, new product introductions, and procedure generation and/or revision.
Monitors production schedules. Troubleshoots scheduling conflicts and coordinates Production resources and with other departments to meet production goals.
Trains new employees for new positions, processes, and retrains others as necessary.
Aids Section Leader in assigning qualified personnel as required to meet weekly production schedule including overtime scheduling as needed. Ensures personnel are properly trained and qualified before assigning tasks.
Complies with and enforces GMP/GDP standards in order to minimize cross contamination, holding personnel directly accountable for compliance.
Ensures housekeeping standards are followed and area is maintained during shift.
Follows all departmental and company safety policies in order to prevent injury to self and others.
Backfills associates in the processing rooms as needed.
Trains and audits production employees to ensure current approved SOP’s are followed.
Supports and promotes all Environmental, Health & Safety initiatives to ensure compliance with corporate and other regulations.
Performs other duties in order to meet department's production schedule or to comply with cGMPs.
Works as a member of the team to achieve all outcomes.
Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.
Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion.
Ensures area housekeeping / 5S initiatives are sustained, and all other relevant duties as assigned.
Works as a member of the team to achieve all outcomes.
Education
General education degree (GED)/ Master degree preferable.
Knowledge, Skills and Abilities
Demonstrates thorough leadership, coaching skills, manufacturing expertise, safety measures knowledge, time management, organizational skills, and the ability to motivate workers.
Understands, adheres to, practices Current Good Manufacturing Practices (cGMPs) and to observe safety, environmental, and security policies and procedures during the performance of all assigned responsibilities.
Computer knowledge (e.g. SAP, Web Navigation, Email, MS Word and MS Excel).
Ability to read English and comprehend documents such as policies, Standard Operating Procedures, batch records and cleaning procedures.
Ability to write in English, and complete batch record documentation.
Ability to speak English effectively.
Must be able to use basic mathematical calculations in multi-level/complex formulas using whole numbers, common fractions, and decimals, following rounding and significant figure rules.
Ability to apply common sense understanding to carry out detailed written and oral instructions.
Ability to apply problem solving technics to address problems involving a few variables in standardized situations.

Experience

4+ years’ experience in a fast-paced, Lean Manufacturing environment required. Experience in a GMP environment preferred (pharmaceutical manufacturing/ biotechnology).
3+ years experience in aseptic environments, sterile filling, or aseptic technique preferred.
3+ years experience with Blow-Fill-Seal (BFS) manufacturing highly preferred.
Must be able to fluently read, write and speak in English.

Seniority level

Seniority level
Mid-Senior level

Employment type

Employment type
Other

Job function

Job function
Management and Manufacturing
Industries
Pharmaceutical Manufacturing

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