Sr. Cleaning Validation Engineer / SME (Onsite / So. California)

ProPharma; Raleigh (NC); On-site; USD 100,000 - 130,000; Part time

Job summary

A prominent consulting company seeks a Sr. Cleaning Validation Engineer to lead validation projects in Southern California. This remote position requires expertise in cleaning validation methodologies and regulatory compliance, with a focus on improving quality assurance practices. Ideal candidates will have a strong background in biopharmaceutical manufacturing and hands-on experience in a cGMP environment.

Qualifications

• Minimum of seven years of experience required.
• Experience with cGMP manufacturing is essential.
• Expertise in execution of cleaning studies for biological products.

Responsibilities

• Serve as the Cleaning Validation lead of a cross-functional team.
• Write and review technical documentation and cleaning validation protocols.
• Assist in regulatory submissions and manage contractors.

Skills

Cleaning validation principles

Regulatory compliance

Risk-based approach

Education

Bachelor’s Degree in Science, Engineering or a related field

Job description

Join to apply for the Sr. Cleaning Validation Engineer / SME (Onsite / So. California) role at ProPharma

1 day ago Be among the first 25 applicants

Join to apply for the Sr. Cleaning Validation Engineer / SME (Onsite / So. California) role at ProPharma

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

This is 100% onsite in So. California. Must be comfortable in a Lead role.

Job Responsibilities

• Serve as the Cleaning Validation lead of cross functional team and able to provide guidance during planning, designing and development of projects.
• Write and review technical documentation (cleaning cycle development reports, SOPs, system lifecycle documentation, protocols & reports for engineering and validation testing, cleaning validation master plans)
• Creation, execution of Cleaning Validation Protocols, including identification and resolution of non-conformances/deviations.
• Assist in preparation of regulatory submissions and presents validation in respective SME areas to regulatory authorities during regulatory inspections.
• Manage contractors performing system qualifications, ensure the quality of completed deliverables.
• Report status and progress of qualification activities or projects to the Leadership team.
  
  

Knowledge & Skills

• Demonstrated knowledge of cleaning validation principles, methodology and life-cycle associated practices.
• Proven experience and expertise in executing cleaning studies for biological products.
• Experience with cleaning validation programs in multi-product facilities, including biological products, complex small molecule formulations, potent and non-potent products.
• Demonstrated ability to use a risk-based approach for defining cleaning validation approach for new products.
• Demonstrated knowledge of biopharmaceutical manufacturing including drug product formulation and fill/finish operations.
• Experience with automated cleaning processes (CIP and parts washers) as well as manual cleaning and sanitization operations.
• Experience with qualification of automated cleaning processes and oversight of cleaning cycle development activities.
  
  

Education & Experience

• A Bachelor’s Degree in Science, Engineering or a related field with a minimum of seven (7) years of experience.
• Knowledge of the cleaning validation role inside of a cGMP manufacturing environment.
• Experience working with the regulations and requirements for biologics or pharmaceuticals.
• Knowledge of scientific and engineering principles in the biopharmaceutical industry.
• Proven track record to create, review, and execute qualification protocols and associated validation lifecycle documentation, including identification and resolution of non-conformances /deviations.
• Automated equipment and system qualification experience in a cGMP environment for process and manufacturing equipment and systems.
• Knowledge and experience with life-cycle approach to cleaning validation in multi-product facility.
  
  

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Part-time

Job function

• Job function

  Quality Assurance

• Industries

  Business Consulting and Services

Referrals increase your chances of interviewing at ProPharma by 2x

Get notified about new Senior Validation Engineer jobs in Raleigh, NC.

Principal Quality Engineer/Manager (Business Systems) - Remote

Quality Assurance Operations Engineer DSM - Night

Senior ServiceNow Developer (Multi-domain / ITSM)

Raleigh, NC $120,000.00-$190,000.00 1 day ago

Senior ServiceNow Developer (Multi-domain / ITSM)

Cary, NC $120,000.00-$190,000.00 1 day ago

Senior ServiceNow Developer (Multi-domain / ITSM)

Raleigh, NC $120,000.00-$190,000.00 20 hours ago

Senior ServiceNow Developer (Multi-domain / ITSM)

Cary, NC $120,000.00-$190,000.00 20 hours ago

Durham, NC $84,000.00-$138,600.00 2 months ago

Senior Principal Software Quality Engineer

Supplier Quality Engineer - Lithium-ion Battery Manufacturing

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.