CSV

Trinity Consultants - Advent Engineering; Massachusetts; Presencial; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

Trinity Consultants - Advent Engineering seeks a skilled Validation Engineer to join the ADVENT team. The role focuses on quality system documentation, design validation, and 21 CFR Part 11 compliance within FDA-regulated projects for pharmaceutical facilities.

You will draft URS, IQ, OQ, PQ protocols, coordinate validation activities, review data integrity, and support tech transfer with R&D and manufacturing. DeltaV software experience and strong technical writing are essential for success.

Formación

• Must have strong knowledge of Quality System documentation and validation practices.
• Experience authoring URS, IQ, OQ and PQ protocols for GMP/GLP projects.
• Solid understanding of FDA regulatory requirements and 21 CFR Part 11.
• Excellent technical writing and documentation skills.

Responsabilidades

• Draft and implement Quality System documentation designed to establish good validation practices.
• Author URS, IQ, OQ and PQ protocols and execute them in compliance with GDP guidelines and internal quality standards.
• Design validation approaches, supported by statistical analyses, coordinate all validation activities and draft results reports.
• Perform Data Integrity Assessments and review systems against 21 CFR Part 11.
• Provide input on user/functional requirements and interface with manufacturers for validation.
• Support non-engineering staff to ensure technology transfer and continuous improvement.
• Review DeltaV software and design test protocols; ensure regulatory compliance.

Conocimientos

Quality System documentation

URS/IQ/OQ/PQ authoring

FDA regulatory compliance

Technical writing/presentation

Educación

B.S./M.S. in engineering

Herramientas

DeltaV

MS Office

Descripción del empleo

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 project

s.
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 compani

es.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 s

et.
This is an outstanding opportunity to join our growing t

eam!
Responsibili

• ties:Draft and implement Quality System documentation designed to establish good validation practices within the organiza
• tion.Author URS, IQ, OQ and PQ protocols and execute them in compliance with GDP guidelines and internal quality stand
• ards.Design validation approaches, supported by appropriate statistical analyses, perform and/or coordinate all validation activities, analyze and assemble results, and draft validation rep
• orts.Perform Data Integrity Assessments and review systems against 21 CFR Pa
• rt 11Provide 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 improve
• ment.Execute assigned duties on time and pro-actively telegraph delays and other issues to validation manager and other relevant stakehol
• ders.Review DeltaV software and specifications to design test proto
• cols.Comply with all regulatory, corporate, and Quality System pol
• tions:B.S. / M.S. in engineering or another relevant disci
• pline.Minimum of 4+ years of experience working within an FDA regulated environment. Experience with upstream and downstream equipment is highly desi
• rable.2+ years’ experience utilizing DeltaV. Capable of interacting with software and designing protocols for DeltaV software customiza
• tions.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 document
• ation.Proficient in Microsoft Word, Excel, Power
• Point.Must be able to work independently with adequate supervision, multi-task, and support several projects simultane
• ously.Must demonstrate strong communication, interpersonal and teamwork s
• kills.A strong understanding of technical writing and presentation skills is req