Pinnaql
Base pay range
$31.00/hr - $45.00/hr
Pinnaql is a trusted consulting partner to regulated life sciences companies, providing deep technical, validation, and quality expertise across every stage of the product lifecycle. We partner with pharmaceutical, biotech, and medical device organizations to navigate complexity, accelerate project timelines, and maintain a strong state of compliance and audit readiness.
We are currently seeking a
CQV Project Scheduler
who will coordinate, and oversee all Commissioning, Qualification, and Validation (CQV) activities for a biotechnology manufacturing site in Norwood, MA. This role blends technical CQV expertise with project scheduling, resource planning, and cross-functional coordination. The ideal candidate has strong startup experience, deep understanding of GMP requirements, and proven ability to build and maintain integrated CQV schedules using industry tools including Smartsheet.
This is an onsite 6 month contract position in Norwood, MA. Compensation will be paid on an hourly basis, with travel/lodging expenses reimbursed if applicable. Engagement may be structured as either W-2 or 1099. Candidates must be authorized to work for any employer in the United States without visa sponsorship.
Key Responsibilities CQV Project Scheduler
Schedule CQV activities for utilities, equipment, automation, and process systems.
Develop, manage and schedule CQV execution strategies, resource plans, and deliverables.
Follow up CQV documentation status (URS, DQ, IQ/OQ/PQ protocols, summary reports).
Schedule activities for CQV risk assessments, deviations, change controls, and CAPAs.
Scheduling & Project Controls
Develop, maintain, and optimize integrated CQV schedules using Primavera P6, MS Project, and Smartsheet.
Create weekly and monthly look-ahead schedules and critical-path analyses.
Track schedule progress, identify constraints, and implement mitigation plans.
Coordinate schedule inputs across construction, automation, engineering, and manufacturing.
Prepare dashboards, milestone reports, and schedule updates for stakeholders.
Cross-Functional Coordination
Facilitate daily and weekly CQV coordination meetings.
Manage TOP (Turnover Package) completions, FAT/SAT readiness, and commissioning interfaces.
Align CQV milestones with mechanical completion, automation readiness, and process tech transfer.
Communicate risks, impacts, and timeline strategies to leadership teams.
Coordinate vendor documentation, FAT/SAT execution, and punch list closeout.
Manage vendor timelines and verify compliance with CQV requirements.
Ensure timely delivery of validated systems.
Qualifications
Bachelor’s degree in Engineering, Life Sciences, or closely related field.
PMP, PMI-SP, or ASQ certification preferred.
5+ years of experience in CQV, project scheduler and management, or biotech facility startup.
Proven experience managing CQV schedules and deliverables using Smartsheet.
Demonstrated experience in commissioning and validation of biotech systems:
Clean utilities (WFI, Clean Steam, CDA, Nitrogen)
HVAC/cleanrooms
Upstream/downstream systems
Automation/SCADA/DCS systems
Strong understanding of cGMP, 21 CFR Part 11, GAMP 5, and regulatory expectations.
Technical Skills
Proficiency in Primavera P6 and/or MS Project.
Ability to interpret engineering drawings, P&IDs, system flow diagrams, and TOP documentation.
Strong data analysis, reporting, and documentation skills.
Soft Skills
Excellent communication and stakeholder management abilities.
Strong organizational, planning, and problem‑solving skills.
Ability to work independently and in a fast‑paced, dynamic environment.
High attention to detail and commitment to quality.
At Pinnaql, 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 your opportunity to make a meaningful difference. You'll help shape the future of healthcare and technology, working alongside a purpose-driven team that's as ambitious as it is supportive.
Excited to build something meaningful together? We look forward to hearing from you!
Pinnaql 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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Pinnaql is a trusted consulting partner to regulated life sciences companies, providing deep technical, validation, and quality expertise across every stage of the product lifecycle. We partner with pharmaceutical, biotech, and medical device organizations to navigate complexity, accelerate project timelines, and maintain a strong state of compliance and audit readiness.
We are currently seeking a
CQV Project Scheduler
who will coordinate, and oversee all Commissioning, Qualification, and Validation (CQV) activities for a biotechnology manufacturing site in Norwood, MA. This role blends technical CQV expertise with project scheduling, resource planning, and cross-functional coordination. The ideal candidate has strong startup experience, deep understanding of GMP requirements, and proven ability to build and maintain integrated CQV schedules using industry tools including Smartsheet.
This is an onsite 6 month contract position in Norwood, MA. Compensation will be paid on an hourly basis, with travel/lodging expenses reimbursed if applicable. Engagement may be structured as either W-2 or 1099. Candidates must be authorized to work for any employer in the United States without visa sponsorship.
Key Responsibilities CQV Project Scheduler
Schedule CQV activities for utilities, equipment, automation, and process systems.
Develop, manage and schedule CQV execution strategies, resource plans, and deliverables.
Follow up CQV documentation status (URS, DQ, IQ/OQ/PQ protocols, summary reports).
Schedule activities for CQV risk assessments, deviations, change controls, and CAPAs.
Scheduling & Project Controls
Develop, maintain, and optimize integrated CQV schedules using Primavera P6, MS Project, and Smartsheet.
Create weekly and monthly look-ahead schedules and critical-path analyses.
Track schedule progress, identify constraints, and implement mitigation plans.
Coordinate schedule inputs across construction, automation, engineering, and manufacturing.
Prepare dashboards, milestone reports, and schedule updates for stakeholders.
Cross-Functional Coordination
Facilitate daily and weekly CQV coordination meetings.
Manage TOP (Turnover Package) completions, FAT/SAT readiness, and commissioning interfaces.
Align CQV milestones with mechanical completion, automation readiness, and process tech transfer.
Communicate risks, impacts, and timeline strategies to leadership teams.
Coordinate vendor documentation, FAT/SAT execution, and punch list closeout.
Manage vendor timelines and verify compliance with CQV requirements.
Ensure timely delivery of validated systems.
Qualifications
Bachelor’s degree in Engineering, Life Sciences, or closely related field.
PMP, PMI-SP, or ASQ certification preferred.
5+ years of experience in CQV, project scheduler and management, or biotech facility startup.
Proven experience managing CQV schedules and deliverables using Smartsheet.
Demonstrated experience in commissioning and validation of biotech systems:
Clean utilities (WFI, Clean Steam, CDA, Nitrogen)
HVAC/cleanrooms
Upstream/downstream systems
Automation/SCADA/DCS systems
Strong understanding of cGMP, 21 CFR Part 11, GAMP 5, and regulatory expectations.
Technical Skills
Proficiency in Primavera P6 and/or MS Project.
Ability to interpret engineering drawings, P&IDs, system flow diagrams, and TOP documentation.
Strong data analysis, reporting, and documentation skills.
Soft Skills
Excellent communication and stakeholder management abilities.
Strong organizational, planning, and problem‑solving skills.
Ability to work independently and in a fast‑paced, dynamic environment.
High attention to detail and commitment to quality.
At Pinnaql, 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 your opportunity to make a meaningful difference. You'll help shape the future of healthcare and technology, working alongside a purpose-driven team that's as ambitious as it is supportive.
Excited to build something meaningful together? We look forward to hearing from you!
Pinnaql 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.
#J-18808-Ljbffr