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Manufacturing Unit Leader- Pharma

Onsite, El Paso, TX

応募
求人ID
R-548209
Category
Operations
Location
エル・パソ, テキサス州

チームワークとリアルな社会的インパクトを基盤とした製造のキャリアを築く

BDの製造部門では、患者さんや医療従事者が日々頼りにしている医療テクノロジーを生み出しています。最先端の設備を使った実践的な業務に携わり、厳格な品質・安全基準に従いながら、世界中のヘルスケアシステムに安定した供給を届ける重要な役割を担います。

経験豊富なオペレーターの方も、これから技術スキルを磨きたい方も、BDには充実したサポート環境、明確な期待値、そして成長の機会があります。BDは意義ある仕事に真摯に取り組むことにコミットしている企業であり、あなたはその中で働くことになります。世界最大級のメドテックカンパニーの一員として、世界のヘルスケアシステムを支える大規模な製造に携わり、ケアを必要とする現場に貢献することができます。

We are the people who give possibilities purpose

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

The Pharma Manufacturing Unit Leader (MUL) is responsible for leading end-to-end manufacturing operations within the Pharma unit, ensuring strict compliance with regulatory standards (FDA, GMP) while driving operational excellence and delivering business performance targets. This role oversees cross-functional teams to ensure safe, high-quality, and efficient production, aligned with BD’s transformation, compliance remediation, and continuous improvement initiatives.

As a Pharma Manufacturing Leader, this position operates in a highly controlled environment involving chemical and biological products, where risk is directly associated with dose accuracy, product potency, and contamination control. The role places a critical emphasis on robust process control, sterility assurance, and reproducibility to guarantee consistent product quality and patient safety.

Job Responsibilities:

Operational Leadership

  • Lead end-to-end daily manufacturing operations for the Pharma unit, ensuring strict adherence to production plans, safety protocols, and quality standards.

  • Provide clear and consistent direction to frontline leaders and production teams across all shifts to ensure alignment and execution discipline.

  • Drive effective implementation of Tiered Management and Daily Management Systems (TMS) to establish clear priorities and maintain operational control.

  • Oversee core pharma operations, including formulation, aseptic processing, and filling activities.

  • Maintain daily focus on:

  • Deviations and batch disposition

  • Environmental monitoring and cleanroom compliance

  • Sterility assurance and contamination control

  • Operate with a low tolerance for process variation, ensuring consistency and reproducibility.

  • Manage changes through a highly structured change control process, recognizing that:
    Every change carries potential regulatory and validation impact (changes may require re-validation, requalification, or regulatory approval).

  • Ensure strict adherence to:

  • Batch record review and documentation practices

  • QC testing and formal release processes

  • Oversee operations within highly controlled environments, including:

  • Cleanroom classifications (Grades A–D)

  • Environmental and contamination controls

  • Gowning, airlocks, and facility compliance standards

  • Recognize that facilities and utilities are integral to process validation and product quality.

Compliance & Quality

  • Ensure full compliance with FDA regulations, GMP standards, BD Quality Systems, and internal procedures, maintaining an always audit-ready environment.

  • Lead inspection readiness and actively support regulatory audits (FDA, internal, and external).

  • Drive timely and effective resolution of deviations, non-conformances (NCRs), and audit findings through robust CAPA processes.

  • Reinforce a strong quality culture with accountability at all levels, grounded in the principle:
    Follow the process exactly and prove every batch meets specification.”

  • Maintain focus on critical pharma risks including dose accuracy, potency, and contamination control.

People Leadership & Engagement

  • Lead, coach, and develop supervisors and production teams to build a high-performing, compliant, and accountable organization.

  • Ensure adequate staffing, capability building, and succession planning for business-critical roles.

  • Demonstrate discipline, rigor, and a zero-tolerance mindset for deviations.

  • Foster a culture of strong governance, documentation excellence, and audit readiness.

  • Balance operational performance with compliance priorities by:

  • Driving compliance discipline and deviation reduction

  • Accepting structured, deliberate decision-making processes

  • Maintaining focus on contamination control, batch release, and inspection readiness.

  • Promote BD Values, a strong Speak Up culture, and an inclusive, respectful work environment.

Operational Excellence & Continuous Improvement

  • Lead Lean and BD Excellence initiatives, including Kaizen events, process standardization, and waste elimination.

  • Deliver productivity improvements and cost targets aligned with the Cost-to-Win (CTW) strategy.

  • Leverage KPIs and data analytics to drive performance, with particular focus on deviation reduction, batch release efficiency, and right-first-time execution.

  • Support Factory Blueprint implementation and sustain standard work practices across the unit

Safety & EHS

  • Ensure compliance with EHS standards and promote a zero-incident safety culture.

  • Address risks proactively and lead investigations for safety incidents.

  • Partner with EHS to drive preventive actions and regulatory compliance.

Cross-functional Collaboration

  • Partner with Quality, Engineering, Maintenance, Supply Chain, and HR to ensure seamless and compliant operations.

  • Support new product introductions (NPI), validation activities, and process transfers.

  • Align resources to meet production and business priorities.

BD Excellence, TMS, and Continuous Improvement

  • Lead the TMS cycle and set the 24‑hour direction for the Manufacturing Unit.

  • Sustain BD Excellence through Daily Tier Meetings (DTM), Clean/Inspect/Lubricate (CIL/CL) standards, and loss elimination practices.

  • Drive short- and long-term improvements aligned with SQDCP (Safety, Quality, Delivery, Cost, People) objectives.

Other Responsibilities

  • Perform additional duties as required to support the needs of the business and site operations.

Education and Experience:

  • Bachelor’s Degree in Engineering, Life Sciences, Manufacturing, or related field required. Master’s Degree preferred

  • 5+ years of manufacturing experience in Pharma is required.

  • Minimum 3–5 years in people leadership roles

  • Strong experience with FDA regulations, GMP compliance, and audit management

  • Proven track record in continuous improvement (Lean, Six Sigma preferred)

  • Flexibility to support multiple shifts and business needs

  • Ability to work in a fast-paced, highly regulated manufacturing environment.

Knowledge and Skills:

  • Strong knowledge of pharmaceutical/medical device manufacturing processes

  • Experience with deviation management, CAPA, and quality systems

  • Familiar with ERP systems (e.g., SAP, Workday) and production planning tools

  • Data-driven mindset with ability to analyze and act on performance metrics

  • Strategic thinking and execution

  • Strong decision-making and problem-solving skills

  • Effective communication across all organizational levels

  • Change management and transformation leadership

  • Collaboration and influence across cross-functional teams

Work Environment:

On‑site role in a clean, highly regulated, high‑volume medical device/pharma manufacturing facility. Requires interaction with Quality, Production, EHS, Engineering, and Facilities teams.

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visithttps://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Required Skills

Optional Skills

.

Primary Work Location

USA TX - El Paso - Northwestern Dr.

Additional Locations

Work Shift

応募

求められる人物像

BDの製造部門で活躍する人たちには、どのような特長があるでしょうか。以下のような方は、BDの製造部門できっと活躍できるはずです:

  • チームワークを大切にする方
  • 細部にまで注意を払える方
  • 問題解決力のある方
  • 結果志向の方
  • 自発的に行動できる方
  • 信頼できる方

より大きな社会的意義のある仕事に参加する準備はできていますか?

ここは、一貫性、チームワーク、品質を重視する方に向いた環境です。経験豊富なリーダーによるサポート、体系的なトレーニング、明確なプロセスが用意されており、大規模に患者ケアを向上させる製品づくりに貢献することができます。BDで34年のキャリアを持つベテラン社員が、真にインパクトを生み出す製造の仕事の中に見出される誇り、使命、そして可能性をどのように体現しているかをご覧ください。

人を中心に築かれた職場環境

  • 「BDの製品が人々の生活にどのような影響を与えているのかという話を聞くことが、私が自分の役割にワクワクする理由です。毎日、命の危険にさらされている方々を助けるために私たちが製品を出荷していることを知ることで、自己充足感を得ています。」

  • 「私たちの製品に自信を持てるのは、製品組立プロセスに直接携わり、十分な訓練を受けた思いやりのある仲間と働いてきたという私自身の経験だけではなく、どの工程にも高い品質を守るための確かな手順と優れたチームが整っていることを知っているからです。」

  • 「BDのカルチャーはとてもつながりが強く、支え合い、そして社員が大きな誇りを持っています。その誇りは、日々の業務の中にしっかりと表れています。」

  • 「マネジメントチームと私は、社内外の様々なトレーニングリソースとチャネルを積極的に活用し、包括的な人材育成システムを確立するとともに、社員ひとり一人に合わせたトレーニングと能力開発プランを提供してきました。マネジメントチームのメンバーのほとんどが社内昇進によるものであることを誇りに思っています。」

福利厚生

  • 競争力のある報酬

  • 退職金制度

  • 医療保険

  • 有給休暇

  • 育児休暇

  • 従業員支援プログラム(EAP)

  • キャリア開発

  • 報奨・表彰制度

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