Top 22 senior validation Jobs in bend, or

Senior Manager, Manufacturing Operations
Rezolute —Bend, OR
- $165,000 - $180,000 a year
- Full-time
- Microsoft Excel
- Bachelor's degree
- Contracts
- Paid holidays
- Disability insurance
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Senior Picture Archiving & Communications Systems (PACS) Administrator
Central Oregon Radiology Assoc., P.C. —Bend, OR
- From $41.32 an hour
- Weekends as needed
- Hybrid work
- Writing skills
- HIPAA
- Office
- Health insurance
- Dental insurance
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Senior Validation Engineer
Serán BioScience —Bend, OR
- Full-time
- 8 years
- Bachelor's degree
- Conflict management
- Disability insurance
- Health insurance
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Sr Engineer Software Validation
Medline Industries —Redmond, OR
- $101,000 - $152,000 a year
- Full-time
- Computer science
- Computer Science
- Engineering
- Health insurance
- 401(k)
Senior Process Engineer, Spray Drying
Serán BioScience —Bend, OR
- Full-time
- Bachelor of Science
- Travel
- US work authorization
- Disability insurance
- Health insurance
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Senior Scientist, Laboratory Director Research and Lab Services
OREGONS WILD HARVEST —Redmond, OR
- Full-time
- Microsoft Outlook
- Analysis skills
- Senior level
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3d
Senior Engineer, Process Development
Serán BioScience —Bend, OR
- Full-time
- Bachelor of Science
- 3 years
- Ability to lift 50 pounds
- Disability insurance
- Health insurance
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Senior Cyber eDiscovery Consultant
Cognicion, LLC —United States
- $95,600 - $145,400 a year
- Full-time
- Remote
- Background check
- Mid-level
- Bachelor's degree
- Health savings account
- Health insurance
Senior DevOps Engineer – Data Engineering
innoVet Health, LLC —United States
- From $140,000 a year
- Full-time
- Remote
- HIPAA
- SQL
- AWS
- Health insurance
- Dental insurance
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9d
Sr. Sales Executive (Pharma sales req. OTE: $350K+)
#twiceasnice Recruiting —United States
- $150,000 - $175,000 a year
- Full-time
- Remote
- Up to 50% travel
- 5 years
- Travel
- Health insurance
- Paid time off
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1d

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Senior Picture Archiving & Communications Systems (PACS) Administrator
Central Oregon Radiology Assoc., P.C. —Bend, OR
Dedicated space/office must be free from distractions and background noise (personal calls, visitors, pets, TV, children, etc.). Must provide your own phone.
From $41.32 an hour
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Senior Project Manager - Construction
Ascension Construction Solutions —Columbus, OH
Coordinate with management and engineering staff to develop solutions to field problems. Oversee total construction effort to ensure project is constructed in…
$100,000 - $150,000 a year
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Senior Project Manager - Data Center Construction
Michael Page —Columbus, OH
Oversee project planning, scheduling, budgeting, and reporting, including daily, weekly, and monthly field updates and change order validation.
$120,000 - $160,000 a year
10d

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Senior Manager, Manufacturing Operations

Rezolute -
Bend, OR

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Job Details

Full-time
$165,000 - $180,000 a year

Benefits

Paid holidays
Disability insurance
Health insurance
Dental insurance
Tuition reimbursement
Vision insurance
401(k) matching
Gym membership

Qualifications

Microsoft Excel
Document control within pharmaceutical industry
Pharmaceutical regulatory compliance
Project change management
Production deviation management
GMP
Project management in manufacturing
Schedule management
Bachelor's degree
Quality assurance within pharmaceutical industry
Smartsheet
Microsoft Teams
Bioprocessing
Productivity software
Sterile products production
Production batch record review
Technical Proficiency
Project stakeholder communication
Cross-functional communication
Pharmaceutical manufacturing facility experience

Full Job Description

Rezolute is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI). Our antibody therapy, RZ358 (ersodetug), is designed to treat all forms of HI and has shown substantial benefit in clinical trials and real-world use for the treatment of congenital hyperinsulinism (cHI) and tumor hyperinsulinism (tHI).

Rezolute is seeking a seasoned professional to support its late-stage and pre-commercial external manufacturing operations. The Senior Manager of Manufacturing Operations will be a proactive, self-directed individual with a strong technical foundation and a clear understanding of the interface between Pharmaceutical Manufacturing, Quality Assurance, and external partners. This role requires the ability to interpret and communicate complex manufacturing information effectively across internal teams, business stakeholders, and CDMO partners.

This fast-paced role supports execution of manufacturing strategies that ensure reliable, right-first-time, and on-time supply to support global clinical trials and commercialization of RZ358. Reporting to the Senior Director of External Manufacturing, this position supports partnerships with contract development and manufacturing organizations (CDMOs) and contributes to delivery of project milestones across multiple Drug Substance (DS) and/or Drug Product (DP) sites. The individual will work closely with internal SMEs (MSAT and QA), Business stakeholders, and Supplier Relationship Management (SRM) to ensure coordinated execution of manufacturing activities.

Principle Duties and Responsibilities Include:

Support execution of Drug Substance (DS) and/or Drug Product (DP) manufacturing in accordance with approved plans, ensuring alignment with program timelines, supply requirements, and business priorities

Serve as a technically informed liaison to internal SMEs (MSAT and QA), Business stakeholders, and Supplier Relationship Management (SRM) to help ensure manufacturing activities are coordinated and aligned with the Plan of Record (POR)

Apply technical understanding of biologics manufacturing processes to support clear and effective communication across internal teams and CDMOs

Work closely with Supplier Relationship Management (SRM), Business stakeholders, and Procurement (PO) to support scheduling, material readiness, and confirmation of manufacturing operations

Support and help facilitate internal Manufacturing Operations alignment meetings to ensure cross-functional visibility and coordination

Assist in coordination of technology transfer, start-up activities, validation, and clinical/commercial manufacturing to support continuity across CDMO partners

Participate in internal and external technical sub-team meetings, including supplier-facing forums, to ensure consistency in communication and alignment to program and business objectives

Support development and collection of manufacturing risk assessments; track risks and help ensure mitigation plans are progressing and visible to stakeholders

Monitor manufacturing KPIs and communicate trends, risks, or issues to leadership, Business stakeholders, and SRM as appropriate

Coordinate Master Batch Record (MBR) and Electronic Batch Record (EBR) review and approval workflows to ensure completeness and compliance

Support tracking and progression of manufacturing change controls (internal and CDMO) through to closure

Partner with QA and CDMOs to track and support resolution of deviations and investigations

Support alignment of Manufacturing Supply Operational Plans with internal forecasts, program timelines, and business objectives

Facilitate coordination of internal SMEs (QA, MSAT) and stakeholders to support timely execution of program deliverables

Provide input into manufacturing-related scopes of work and contracts to ensure alignment with operational needs, supplier capabilities, and program strategy

Support collaboration with Supplier Relationship Management (SRM) to ensure effective oversight of CDMO performance and partnership health

Support tracking of manufacturing activities against budget and scope in collaboration with Finance, Business stakeholders, and leadership

Contribute to development and use of PMO tools and manufacturing project management best practices

Interface with PMO to support alignment of Tech Ops activities with broader program and business goals

Support readiness activities for late-stage and commercial manufacturing, ensuring processes and documentation are aligned for scale, compliance, and supplier execution

Qualifications/Requirements:

Minimum Bachelor’s degree in a relevant scientific discipline

Minimum 8 years of relevant experience (industry, project management, or related), with small to mid-sized biotech experience preferred

Demonstrated technical understanding of biologics (mAb) manufacturing, including Drug Substance (upstream/downstream) and/or aseptic Drug Product operations

Ability to apply technical knowledge to support cross-functional communication and decision-making across Technical Operations, Business teams, and external partners

Experience working with CDMOs and supporting external manufacturing operations; exposure to supplier or business interface is preferred

Strong organizational and project coordination skills, with the ability to manage multiple activities and timelines

Demonstrated ability to work independently in a fast-paced, matrixed environment

Strong attention to detail and ability to track complex deliverables to completion

Effective interpersonal and communication skills, with the ability to work across technical, operational, and business functions

Basic understanding of cGMP requirements and quality systems, including change controls, deviations, and batch record review

Proficiency in Microsoft Teams, Excel, Word, PowerPoint, and Smartsheet

Rezolute (RZLT) currently anticipates the base salary for Senior Manager Manufacturing Operations role could range from $165,000 to $180,000 and will depend, in part, on the successful candidate’s geographical location and their qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company’s discretion on an individual basis). The compensation described above is subject to change and could be higher or lower than the range described based on current market survey data and the qualifications, education, experience and geographical location of the selected candidate.

Qualifying employees are eligible to participate in benefit programs such as:

Health Insurance (Medical / Dental / Vision)

Disability, Life & Long-Term Care Insurance

Holiday Pay

Tracking Free Vacation Program

401(k) Plan Match

Educational Assistance Benefit

Fitness Center Reimbursement

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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Refine Your Search

senior validation jobs in bend, or

Senior Manager, Manufacturing Operations

Senior Picture Archiving & Communications Systems (PACS) Administrator

Senior Validation Engineer

Sr Engineer Software Validation

Senior Process Engineer, Spray Drying

Senior Scientist, Laboratory Director Research and Lab Services

Senior Engineer, Process Development

Senior Cyber eDiscovery Consultant

Senior DevOps Engineer – Data Engineering

Sr. Sales Executive (Pharma sales req. OTE: $350K+)

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