Product and Process Engineer at Halborn

Oak Hill, New York, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Consumer Goods, Healthcare, PharmaceuticalsIndustries

Requirements

BS degree in Chemistry, Engineering, or related area
Minimum of 3 years in Manufacturing Science, Product Development, or Technical Operations role
Track record of improving products, processes and troubleshooting, execution of technical activities including trials and validation activities (Preferred)
Experienced in technology transfer, with an understanding of the product development process and manufacturing equipment (Preferred)
Able to evaluate potential innovative technology areas relevant to product (Preferred)
Thorough knowledge of GMP and EHS requirements (Preferred)
Demonstrated in-depth knowledge of Quality by Design and risk management approaches (Preferred)
Demonstrates ability to contribute to and effectively influence matrix teams, colleagues in other functions and senior stakeholders (Preferred)
Demonstrated ability to mentor operational staff and support functions (Preferred)
Project management skills (Preferred)
IT Skills: MS Office, SAP, Power BI (Preferred)

Responsibilities

Liaise with Regional and Global Technical, as well as other site functions such as QA, QC, Engineering, and Operations to ensure that proper controls are established and maintained for products to be manufactured in a validated state of control
Implement and maintain continued process verification (CPV), as appropriate, for determined products and processes on site. Incorporate data trending and statistical analysis to verify that processes remain in a validated state of control, and to proactively identify trends which may provide risk to the product
Maintains and periodically reviews product control strategies (PCS) and technical risk assessments (TRA) as required
Provide all necessary information to develop and execute process validation, working across multiple functions to collect the appropriate inputs for validation protocols and authoring validation reports. Validates the manufacturing and packaging process parameters necessary to assure product quality, and incorporates this into the PCS
Lead or contributes to, as required, change controls impacting products or manufacturing processes. Ensure alignment of timelines and activities required for technical changes, product transfers, major deviations, and investigations
Performs risk assessments on cleaning processes, as required for new products, processes, or materials introduced to the site, and ensuring appropriate validation is implemented. This includes HBEL, MACO, residual solvent calculations, and other assessments to support cleaning validation needs. Develops and works with Operations to execute protocols for cleaning validation, and issues validation reports

Skills

Process Engineering

Continued Process Verification

CPV

Statistical Analysis

Data Trending

Product Control Strategies

PCS

Technical Risk Assessments

TRA

CQAs

CPPs

Validated State of Control

Halborn

Cybersecurity for blockchain and digital assets

About Halborn

Halborn specializes in cybersecurity focused on blockchain technology and digital assets. The firm provides security audits, penetration testing, and consulting services to clients in the digital finance sector, including cryptocurrency exchanges and Decentralized Finance (DeFi) companies. Their services help ensure the security of digital assets and financial infrastructure by addressing the specific security threats associated with blockchain technology. Halborn stands out from competitors due to its deep understanding of both blockchain and traditional financial security, which allows them to offer tailored solutions. The company's goal is to protect businesses from security threats, ensuring the safe operation of digital exchanges and the integrity of smart contract infrastructure.

Miami, FloridaHeadquarters

2019Year Founded

$87.5MTotal Funding

SERIES_ACompany Stage

Cybersecurity, Financial ServicesIndustries

51-200Employees

Benefits

Health Insurance

Unlimited Paid Time Off

Company Equity

Risks

Increased targeting of Bitcoin hot wallets poses risks to Halborn's clients.

AI-powered social media bot farms could introduce new cyber threats.

Ongoing vulnerabilities in smart contracts remain a challenge for Halborn's services.

Differentiation

Halborn specializes in blockchain and digital asset cybersecurity, setting it apart.

The company offers high-level security audits and penetration testing for DeFi clients.

Halborn's expertise in both blockchain and traditional finance security is unique.

Upsides

Growing demand for blockchain security boosts Halborn's market potential.

Partnerships with Tholos and Orion Protocol enhance Halborn's Web3 security reputation.

Tokenized real-world assets present new opportunities for Halborn's security solutions.

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