Engineering Change Management Lead
Engineering Change Management Lead
Posted on :
19-08-2025
Employer Active
1 Vacancy
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Jobs by Experience
5years
Monthly Salary
$ 85000 - 120000
Vacancy
1 Vacancy
Posted on :
19-08-2025
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
- Define and measure success metrics and monitor change progress
- Document control management
- Develop change management plans define metrics and identify risks
- Create and support Corrective Action Plans
- Assess change impact and communicate summary of impact
- Maintain Quality Management System (experience with TrackWise is preferred)
- Manage various facilities packaging and process equipment and aseptic operation projects
- Coordinate and execute all other projects (may include clean room/classified area modifications equipment upgrades/modifications equipment installation etc.)
- Plan coordinate and monitor aseptic operations change control processes (i.e. aseptic operations ISO 8 operations hydration filling and component preparation)
Requirements
- Bachelor s Degree in engineering or another relevant field
- Knowledge and experience with ECM defined by ISPE Baseline guide 5
- 2 plus years of experience in change control management and/or engineering
- Well-versed in planning coordinating and executing Change Control processes (specifically in packaging/processing and clean room area modifications)
- Familiarity with TrackWise
- Advanced experience with Vial Packaging Lines Solid Dose Lines Aseptic Fill Lines Lyos (freeze dryers) Parts Washers and Autoclaves
- Proficient in ISO 8 and ISO 5
- Exceptional communication skills (verbal and written)
- Strong organizational and problem-solving skills
- Excellent math and analytical abilities
Benefits
Offering a full suite of benefits PSC Biotech 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 - PSC 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 24-Hour Fitness and more).
- Financial Perks and Discounts
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.
#LI-TP1
Bachelor s degree in Information Technology, Computer Science, or a related field. A minimum of 4 years of experience in IT systems management, specifically in the R&D or clinical sector. Strong knowledge of IT change management processes. Experience in business analysis and project management is a plus. Experience with Veeva systems, particularly in clinical and regulatory environments. Proficiency in IT Service Management systems (e.g., ServiceNow), identity management tools, and integration technologies such as API-based solutions. Strong understanding of SDLC (System Development Life Cycle) processes, particularly in regulated environments. Experience with reporting tools (e.g., PowerBI) and relational databases. Excellent communication skills with the ability to collaborate effectively with cross-functional teams. Ability to work well in a fast-paced environment. Ability to work independently with minimal supervision. Effective interpersonal and communication skills. Able to support Pacific or Central Standard Times working hours.
Employment Type
Full Time
Key Skills
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