Validation Engineer
Validation Engineer
Posted on :
19-12-2024
Employer Active
1 Vacancy
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Jobs by Experience
3-5years
Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
19-12-2024
Job Description
BioTechnique is a sterile injectable full service CDMO providing cytotoxic and therapeutic sterile injectable fillfinish services. From IND applications through commercial scale production we provide formulation and compounding fillfinish and lyophilization services for a wide variety of liquid injectables. BioTechnique utilizes our team s expertise to create a process design for our clients products that best suits their needs.
The Experience
With operations spanning the globe and featuring a multicultural team BioTechnique is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team you will be offered the ability to feel inspired in your career explore your professional passions and work alongside a group of people who will value and nurture your talents.
We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such you will not only be offered a compensation and benefits structure that rewards you but also be provided with the tools that will help you grow and learn.
At BioTechnique it s about more than just a job it s about your career and your future.
Your Role
We are hiring a highly motivated and experienced Validation Engineer to join our team in York PA. This role will ensure that all manufacturing processes and equipment are validated and operate in compliance with regulatory standards while implementing effective process improvements.
- Develop and execute validation protocols (IQ OQ PQ) for pharmaceutical manufacturing processes equipment and systems.
- Conduct risk assessments root cause analysis and deviation investigations. Implement risk mitigation and solutions for improvement ensuring compliance with regulatory requirements.
- Analyze data to identify trends deviations and areas for improvement.
- Troubleshoot and resolve issues related to equipment and process performance.
- Prepare and maintain comprehensive documentation including validation protocols plans reports and standard operating procedures.
- Collaborate with crossfunctional teams to ensure alignment on validation activities and project timelines.
- Support the mentoring and coaching junior level team members.
- Additional responsibilities as assigned.
Requirements
- Bachelors degree in relevant engineering or scientific discipline.
- 35 years of proven validation experience in the pharmaceutical manufacturing industry.
- Advanced knowledge of regulatory requirements and guidelines.
- Strong technical writing skills and knowledge of full lifecycle documentation.
- Excellent problemsolving and analytical skills.
- Excellent communication and interpersonal skills.
- Attention to detail and commitment to quality and compliance.
- Proactive with strong organization time management and project management abilities.
Benefits
Offering a full suite of benefits BioTechnique is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance so you not only enjoy your work but also have the time and resources to live your life happy and healthy.
- Medical Dental and Vision BioTechnique pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
- Insurance options for Employee Assistance Programs Basic Life Insurance Short/Long Term Disability and more.
- 401(k) and 401(k) matching
- PTO Sick Time and Paid Holidays
- Education Assistance
- Pet Insurance
- Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness 24Hour Fitness and more
- Financial Perks and Discounts
Equal Opportunity Employment Statement:
BioTechnique is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees interns and applicants for employment. Consistent with this commitment our policy is to comply with all applicable federal state and local laws concerning employment discrimination. Accordingly the Company prohibits discrimination against qualified employees interns and applicants in all aspects of employment including but not limited to: recruitment interviewing hiring (or failure or refusal to hire) evaluation compensation promotion job assignment transfer demotion training leaves of absence layoff benefits use of facilities working conditions termination and employersponsored activities and programs including wellness social and recreational programs. Employment decisions will be made without regard to an applicant s employee s or intern s actual or perceived: race color religion sex (including pregnancy gender identity and sexual orientation) national origin age (40 or older) disability genetic information or any other status protected by law.
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Bachelor's degree in relevant engineering or scientific discipline. 3-5 years of proven validation experience in the pharmaceutical manufacturing industry. Advanced knowledge of regulatory requirements and guidelines. Strong technical writing skills and knowledge of full lifecycle documentation. Excellent problem-solving and analytical skills. Excellent communication and interpersonal skills. Attention to detail and commitment to quality and compliance. Proactive with strong organization, time management, and project management abilities.
Employment Type
Full Time
Key Skills
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