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.
Job Summary:
Assists Section Leader in providing daily leadership to employees in the Manufacturing department to ensure safety and quality, maximizing productivity and efficiency while fostering a positive work environment, and serves as Section Leader in their absence. Plans and communicate daily production needs within the team, including but not limited to material weighing, blending, and aseptic filling (BFS) process steps in cleanroom environments. Leads manufacturing teams on all assigned job duties, communicating overtime needs, training of new hires, and helping R&D with new processes as Subject Matter Expert. Keeps the section leader and/or supervisor informed of all issues that occur on the shift.
Key Responsibilities:
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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.
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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.
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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.
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Ensures Operators monitor and document the critical process parameters during the manufacturing process.
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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.
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Works with Quality Assurance and Engineering to ensure the manufacturing process meets quality specifications.
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Acts as Subject Matter Expert on production procedures to support investigations, CAPAs, projects, new product introductions, and procedure generation and/or revision.
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Monitors production schedules. Troubleshoots scheduling conflicts and coordinates Production resources and with other departments to meet production goals.
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Trains new employees, new positions, processes, and retrains as necessary.
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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.
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Complies with and enforces GMP/GDP standards in order to minimize cross contamination, holding personnel directly accountable for compliance.
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Ensures housekeeping standards are followed and area is maintained during shift.
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Follows all departmental and company safety policies in order to prevent injury to self and others.
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Backfills associates in the processing rooms as needed.
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Trains and audits production employees to ensure current approved SOP’s are followed.
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Supports and promotes all Environmental, Health & Safety initiatives to ensure compliance with corporate and other regulations.
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Performs other duties in order to meet department's production schedule or to comply with cGMPs.
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Works as a member of the team to achieve all outcomes.
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Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.
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Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion.
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Ensures area housekeeping / 5S initiatives are sustained, and all other relevant duties as assigned.
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Works as a member of the team to achieve all outcomes.
Education
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High school diploma or general education degree (GED)
Knowledge, Skills and Abilities
o Demonstrates thorough leadership, coaching skills, manufacturing expertise, safety measures knowledge, time management, organizational skills, and the ability to motivate workers. o 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. o Computer knowledge (e.g. SAP, Web Navigation, Email, MS Word and MS Excel). o Ability to read English and comprehend documents such as policies, Standard Operating Procedures, batch records and cleaning procedures. o Ability to write in English, and complete batch record documentation. o Ability to speak English effectively. o 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. o Ability to apply common sense understanding to carry out detailed written and oral instructions. o Ability to apply problem solving technics to address problems involving a few variables in standardized situations.
Experience
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4+ years’ experience in a fast-paced, Lean Manufacturing/Packaging environment required. Experience in a GMP environment preferred (pharmaceutical manufacturing, biotechnology, medical device, or food manufacturing).
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3+ years experience in aseptic environments, sterile filling, or aseptic technique preferred.
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3+ years experience with Blow-Fill-Seal (BFS) manufacturing highly preferred.
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Must be able to fluently read, write and speak in English
Benefits:
Aveva Drug Delivery Systems and DifGen Pharmaceuticals provides a comprehensive benefits plan
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Medical/Dental/Vision Insurance
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Paid Time Off
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401k with employer match
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Paid Holidays and Floating Holiday
Equal Opportunity Employer
