Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
Responsibilities:
- Maintain integrated C&Q schedule (plan/actual/forecast).
- Support schedule impact analysis for C&Q reporting.
- Align with document preparation and execution phases and provide inputs for weekly/monthly forums.
- Escalate any concerns or issues that may be impacting the C&Q schedule.
- Work closely with the Project Integrator to ensure the latest updates on C&Q activities are captured and to stay current with changes in the overall project schedule.
- Run schedule scenarios as needed and assess/communicate impacts to the C&Q schedule.
Qualifications:
- Experience developing and maintaining integrated schedules for Commissioning & Qualification (C&Q) or comparable regulated project work.
- Proficiency with scheduling tools (e.g., Primavera P6 and/or Microsoft Project) and schedule controls practices (baseline management, progress updates, forecasting).
- Ability to perform schedule impact analysis and communicate drivers/risks for C&Q reporting (weekly/monthly).
- Strong coordination skills to align schedule with document readiness (protocols, test scripts, turnover packages) and field execution.
- Clear written and verbal communication; able to support forums and produce schedule visuals/metrics as needed.
Additional Preferences:
- Prior experience supporting CQV deliverables and turnover/handshake processes in GMP/regulated environments.
- Familiarity with progress measurement for C&Q (e.g., protocol readiness, execution, deviations/punchlist closure) and dashboard reporting.
- Experience working onsite and coordinating with construction, QA, engineering, and C&Q leads.
Qualifications:
- Bachelor's Degree in Science or Engineering.
- Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries.
- Must be fully bilingual (English / Spanish) with excellent oral skills.
- Must be proficient using MS Windows and Microsoft Office applications.
- Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
- Technical Writing skills and investigations processes.
- Available to work extended hours, possibility of weekends and holidays.
At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.
Excited to build something meaningful together? We look forward to hearing from you.
Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.
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