CSV/DeltaV

Trinity Consultants - Advent Engineering; Boston (MA); Vor Ort; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

ADVENT Engineering is seeking a Validation Engineer to join a team of engineers focused on design, automation, commissioning, and startup of processes and facilities for pharmaceutical and biotech clients.

Ideal candidates have 4+ years in FDA-regulated environments, DeltaV expertise, and strong technical writing skills to develop URS/IQ/OQ/PQ and related documentation, ensuring compliance with GDP and quality standards.

Qualifikationen

• B.S./M.S. in engineering or a related discipline.
• 4+ years of experience in an FDA-regulated environment.
• 2+ years of DeltaV experience and ability to design protocols for DeltaV software customizations.
• Experience in Design Documentation (URS, FRS, DS, and other engineering specifications) and Validation (IQ/OQ/PQ/CSV).
• Strong knowledge of Computer Systems Validation lifecycle and documentation.
• Proficiency in Microsoft Word, Excel, and PowerPoint.

Aufgaben

• Draft and implement Quality System documentation to establish good validation practices.
• Author URS, IQ, OQ and PQ protocols and execute them per GDP guidelines and internal quality standards.
• Design validation approaches, coordinate validation activities, analyze results, and draft validation reports.
• Perform Data Integrity Assessments and review systems against 21 CFR Part 11.
• Provide input on user and/or functional requirements and interface with Manufacturers to ensure requirements are met.
• Support non-engineering staff to enable technology transfer and continuous improvement.
• Execute assigned duties on time and proactively notify delays to the validation manager.
• Review DeltaV software and specifications to design test protocols.
• Comply with regulatory, corporate, and Quality System policies.

Kenntnisse

Strong communication

Interpersonal skills

Technical writing

Ausbildung

B.S./M.S. in Engineering

Tools

DeltaV

Microsoft Word

Excel

PowerPoint

Jobbeschreibung

Please note: We are only considering W2 candidates at this time. Applications from third-party vendors or C2C arrangements will not be considered.

ADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Head-quartered near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, our company is involved in almost every facet of global pharmaceutical and biotechnology facility design and process engineering and quality system projects.

ADVENT's services include process engineering, automation engineering, project engineering, facility/system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.

The successful candidate will work with a group of engineers involved in the design, automation, commissioning and start-up of various processes, systems and facilities. A combination of strong technical aptitude, automation engineering skills and technical writing are the desired skill set.

This is an outstanding opportunity to join our growing team!

Responsibilities:

• Draft and implement Quality System documentation designed to establish good validation practices within the organization.


• Author URS, IQ, OQ and PQ protocols and execute them in compliance with GDP guidelines and internal quality standards.


• Design validation approaches, supported by appropriate statistical analyses, perform and/or coordinate all validation activities, analyze and assemble results, and draft validation reports.


• Perform Data Integrity Assessments and review systems against 21 CFR Part 11


• Provide input on user and/or functional requirements of current and future processing equipment, and draft appropriate documentation. Additionally, interface with Manufacturers to ensure all relevant user and functional requirements are met.


• Provide support to non-engineering Staff, including those from R&D and Manufacturing, to ensure successful technology transfer and continuous improvement.


• Execute assigned duties on time and pro-actively telegraph delays and other issues to validation manager and other relevant stakeholders.


• Review DeltaV software and specifications to design test protocols.


• Comply with all regulatory, corporate, and Quality System policies

Qualifications:

• B.S. / M.S. in engineering or another relevant discipline.


• Minimum of 4+ years of experience working within an FDA regulated environment. Experience with upstream and downstream equipment is highly desirable.


• 2+ years’ experience utilizing DeltaV. Capable of interacting with software and designing protocols for DeltaV software customizations.


• Experience in the areas of Design Documentation (URS, FRS, DS, and other engineering specifications), Validation (IQ, OQ, PQ, PV, CSV, MVP, etc), Quality Systems (Change Control, Non-Conformances, Requalification, etc)


• Strong knowledge of Computer Systems Validation lifecycle and documentation.


• Proficient in Microsoft Word, Excel, PowerPoint.


• Must be able to work independently with adequate supervision, multi-task, and support several projects simultaneously.


• Must demonstrate strong communication, interpersonal and teamwork skills.


• A strong understanding of technical writing and presentation skills is required.