DeltaV Validation Engineer – FDA QA/CSV Specialist

Trinity Consultants - Advent Engineering; Boston (MA); Sur place; USD 90 000 - 120 000; Plein temps

Résumé du poste

ADVENT Engineering in Boston, MA seeks an experienced Validation Engineer to join our pharmaceutical and biotech project teams. You will draft and implement quality system documentation, author URS/IQ/OQ/PQ protocols, and design validation strategies across GMP facilities.

Responsibilities include data integrity assessments, 21 CFR Part 11 compliance, and collaboration with R&D and Manufacturing to support tech transfer and continuous improvement.

Qualifications

• B.S. / M.S. in engineering or a related discipline is required.
• 4+ years in an FDA-regulated environment; upstream and downstream equipment experience desirable.
• 2+ years' DeltaV experience; capable of interfacing with software and designing DeltaV customization protocols.
• Experience with Design Documentation (URS, FRS, DS, and other engineering specs), Validation (IQ/OQ/PQ/CSV/etc.), Quality Systems (Change Control, Non-Conformances, Requalification).
• Strong knowledge of Computer Systems Validation lifecycle and documentation.
• Proficient in MS Word, Excel, PowerPoint.
• Ability to work independently with adequate supervision, multi-task, and support several projects.
• Strong communication, interpersonal and teamwork skills.
• Strong technical writing and presentation skills.

Responsabilités

• 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.

Connaissances

Technical writing

Communication

Teamwork

Independent work

Formation

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

Outils

DeltaV

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Description du poste

ADVENT Engineering in Boston, MA seeks an experienced Validation Engineer to join our pharmaceutical and biotech project teams. You will draft and implement quality system documentation, author URS/IQ/OQ/PQ protocols, and design validation strategies across GMP facilities.

Responsibilities include data integrity assessments, 21 CFR Part 11 compliance, and collaboration with R&D and Manufacturing to support tech transfer and continuous improvement.