Product and Process Engineer - Maternity Cover at Halborn

Aprilia, Latium, Italy

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Consumer Health, Pharmaceutical ManufacturingIndustries

Requirements

Recognized as the principal point of contact for all aspects of current and previous knowledge on the product(s), performance and end-to-end process, including Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs) and stability
Accountable at site level for maintaining this knowledge and sharing on site and globally as appropriate

Responsibilities

Coordinates, plans and executes development and validation of manufacturing processes and equipment cleaning procedures, working across multiple functions to collect the appropriate inputs for validation protocols and authoring validation reports
Authors documentation required for development / validation trials (protocols / reports, operative instructions, sampling plans, control charts, master formulas, experimental production orders where needed)
Authors Qualitative e Quantitative Composition (QQC) for Dietary Supplement products
Authors production documentation (working instructions, master formulas, cleaning instructions, SAP Data Collection Forms) for routine manufacturing
Liaises 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
Analyzes stability data to support product shelf-life, site programs (e.g. PPRs) and external evaluations (e.g. regulatory notifications and commitments)
Coordinates de-risking and business continuity projects related to raw materials, working closely with suppliers, Quality Supplier, Purchasing, Regulatory Compliance
Implements and maintains continued process verification (CPV), as appropriate, for determined products and processes on site. Incorporates 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
Leads or contributes to, as required, change controls impacting products or manufacturing processes
Ensures alignment of timelines and activities required for technical changes, product transfers, major deviations, and investigations
Performs assessments on cleaning processes, as required for new products, processes, or materials introduced to the site, and ensures 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
Updates SOPs regulating the department activities in line with company guidelines and regulations
Collaborates and supports for technical aspects the other site functions

Skills

Process Development

Process Validation

Technology Transfer

Cleaning Validation

CQAs

CPPs

Stability Studies

Validation Protocols

Validation Reports

Operative Instructions

Sampling Plans

Control Charts

Master Formulas

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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