Validation Engineering Manager
Validation Engineering Manager
Posted on :
03-10-2025
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1 Vacancy
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Job Description
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed manufactured and distributed to the highest standards in compliance with all applicable regulatory requirements.
Our goal is to skyrocket our clients success and you can be a part of our team s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America Europe Asia and the Middle East we are proud of the roles we have fulfilled to help our clients achieve success.
The Experience
With operations spanning the globe and featuring a multi-cultural team PSC Biotech 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 compensation and benefits structure that rewards you but also be provided with the tools that will help you grow and learn.
At PSC Biotech it s about more than just a job it s about your career and your future.
Your Role
This is a W2-Temp 6-month role with potential FTE extension. We are hiring an experienced and motivated Validation Engineering Manager to oversee project management commissioning and qualification activities for facilities utilities and computer systems. This role will drive successful project and deliverable completion adhering to industry standards and regulations.
- Complies with all policies procedures and laws.
- Examines manufacturer and blueprint specifications regarding electrical mechanical and software/computer systems to determine essential parameters.
- Develops Qualification Project Plans and protocols (IQ/OQ/PQ) to test essential installation operation and performance parameters for facilities utilities computer systems or equipment.
- Protocols are approved through established channels; validation protocols are drafted and updated when required.
- Carries out validation and qualification protocols in accordance with applicable SOPs and confirms whether acceptance criteria are satisfied.
- Documents all test data in compliance with cGMP requirements.
- Prepares final reports and secures proper approval.
- Develops and communicates project timelines and status updates.
- Complies with GMP and safety standards SOPs and company policies and procedures.
- Performs related duties as assigned.
- Performs regular assessments of equipment and system qualifications compiles comprehensive summary reports and oversees the management of CAPAs for identified issues. Responsibilities include reviewing change controls deviations work orders IQ/OQ URS drawings and FS/DS as applicable.
- Prepares or updates Site Validation Master Plans.
- Develops and applies FMEAs RCAs and other investigative tools for failures and investigations.
- Performs risk assessments for qualification activities change management or quality investigations.
Requirements
- Bachelors degree in engineering or related technical field.
- 5-7 years of experience within pharmaceutical or related manufacturing facility.
- Experience with manufacturing equipment functional parts including control systems mechanical components and electrical power.
- Strong understanding of regulatory requirements (FDA EMA ICH etc.) and industry standards (GMP GLP GAMP etc.) related to validation and computer systems.
- Strong technical expertise in computerized systems automation and digital analytics.
- Ability to write clear protocols manage deviations and communicate findings effectively.
- Experience with risk assessment methodologies (e.g. FMEA) and root cause analysis.
- Effective communication and interpersonal skills enabling collaboration with diverse cross-functional teams.
- Travel is required. At PSC Biotech many of our projects and clients are located in various regions around the country. Therefore we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations cultures and work environments is essential as it allows our team members to collaborate effectively with clients and colleagues nationally.
Benefits
W2 Temp positions include our medical and sick time benefits.
Equal Opportunity Employment Statement:
PSC 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 employer-sponsored 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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Employment Type
Full Time
Key Skills
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