Sr. Process Validation Engineer

Valspec; New York (NY); On-site; USD 80,000 - 120,000; Full time

Job summary

Valspec is searching for a Process Validation Engineer for a contract position, lasting 8-12 months. The successful candidate will leverage their extensive experience in vaccine manufacturing, ensuring regulatory compliance and contributing to quality improvements. A highly analytical and detail-oriented approach is essential, along with effective communication skills.

Benefits

Competitive compensation

Premium medical benefits

401K match

Tuition reimbursement

Professional development opportunities

Qualifications

• Minimum of 5 years of experience in process validation within a GMP life sciences manufacturing facility.
• Strong understanding of vaccine manufacturing processes and regulatory requirements.
• Familiarity with statistical analysis.

Responsibilities

• Develop and execute validation protocols for new and existing processes, equipment, and systems.
• Prepare and analyze statistical data to ensure quality and reliability.
• Conduct process validation studies to verify manufacturing processes.

Skills

Analytical skills

Problem-solving skills

Communication skills

Education

Bachelor's degree in a relevant scientific or engineering discipline

Tools

Validation software

Job description

Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec’s mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals.

Valspec’s projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies.

Process Validation Engineer (Contract)

Duration:8-12 months

Job Description:

We are seeking a highly skilled Process Validation Specialist to join our team on a contract basis. The ideal candidate will have extensive experience in the vaccine manufacturing process within a GMP life sciences manufacturing facility, similar to those at leading companies in the industry.

Responsibilities:

• Develop and execute validation protocols for new and existing processes, equipment, and systems.
• Design, install, and evaluate quality control processes and statistical methods.
• Prepare and analyze statistical data to identify and maintain quality and reliability of products.
• Ensure compliance with all applicable regulations and standards.
• Work closely with production staff to identify and resolve manufacturing and quality problems.
• Conduct process validation studies to verify that manufacturing processes are capable of producing the desired product quality.
• Identify and implement process improvements to increase the efficiency and effectiveness of the manufacturing process.
• Document validation processes and results for use in audits and regulatory inspections.
• Train staff on validation processes and procedures.
• Conduct risk assessments to identify potential process and product hazards and implement appropriate control measures.

Qualifications:

• Bachelor's degree in a relevant scientific or engineering discipline.
• Minimum of 5 years of experience in process validation within a GMP life sciences manufacturing facility.
• Strong understanding of vaccine manufacturing processes and regulatory requirements.
• Excellent analytical and problem-solving skills.
• Ability to work independently and as part of a team.
• Strong communication and documentation skills.
• Familiarity with statistical analysis and proficiency in using validation software.
• Competitive compensation.
• Opportunity to work with a leading company in the life sciences industry.
• Professional development and growth opportunities.

Additional Information:

This role is a contract position lasting 8-12 months, based in Pennsylvania. The successful candidate will have the opportunity to work with a leading pharmaceutical company and contribute to the development and validation of critical processes and equipment.

Valspec offers a standout culture, fantastic work environment, and has very competitive benefits to include premium medical, 401K match, tuition reimbursement, and other unique incentives.

Candidates must be legally eligible to work in the United States without company sponsorship. Also, we are not interested in working on a corp-to-corp basis with other companies at this time.

Any third-party unsolicited resume submission(s) will immediately become the property of Valspec. Valspec will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established.

Valspec is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.

Create a Job Alert

Interested in building your career at Valspec? Get future opportunities sent straight to your email.

Accepted file types: pdf, doc, docx, txt, rtf

Enter manually

Accepted file types: pdf, doc, docx, txt, rtf

Will you now, or in the future, require sponsorship for employment visa status (e.g. H-1B visa status)? * Select...

U.S. Citizens should select No to this question. Please select Yes or No to designate whether you require sponsorship to work for any U.S. employer, now or in the future.