- Lead and manage projects from initiation to closure, including requirements gathering, design, development, testing, deployment, and maintenance phases.
- Collaborate with cross-functional teams, including designers, developers, architects, and stakeholders, to define project scope, objectives, and deliverables.
- Apply your technical expertise to provide guidance and insights during project design, implementation, and problem-solving activities.
- Lead validation activities across the full project lifecycle, including requirements gathering, planning, execution, and documentation.
- Assist in providing construction support and the A&E construction design process.
- Create detailed design specifications, drawings, and prototypes using industry-standard tools. Conduct testing and analysis to ensure designs meet performance, reliability, and safety criteria.
- Execute project lifecycle documentation, design documentation (URS, FS, DS), and construction control plans.
- Lead change control processes, evaluating proposed changes for their impact on validated processes, equipment, and systems. Maintain accurate and organized validation and change control documentation, including protocols, reports, risk assessments, and change control records.
- Develop and execute commissioning, qualification, and validation strategies, protocols, and plans for equipment, facilities, utilities, and processes.
- Develop comprehensive validation plans, protocols, SOPs, and reports that adhere to regulatory requirements and company guidelines.
- Generate and execute decommissioning/commissioning protocols.
- Analyze validation results, identify deviations or issues, and work collaboratively to develop and implement corrective and preventive actions.
- Participate in regulatory audits and inspections, ensuring that all validation processes, change control practices, and documentation meet regulatory requirements.
- Effectively collaborate with cross functional project teams to drive project completion and deliverables.
- Additional duties may be assigned.
- Bachelor's Degree in engineering.
- 7+ years of design, validation, commissioning, qualification experience within cGMP/Biotech/Pharmaceutical Manufacturing/FDA regulated industries.
- Expertise in developing and executing validation protocols.
- Experienced with the validation of pharmaceutical utilities (RO, Compressed Air, Ambient WFI, air handlers, CIP systems, boilers, etc.), automation (Delta V, BAS, etc.), and cleaning and process validation.
- Strong knowledge of DeltaV, HVAC control, Siemens BAS, MES, and EBM.
- Knowledge of ISPE Baseline Guide Chapter 5 for C&Q.
- Knowledge of ASTM E2500.
- Excellent knowledge of cGMP/FDA regulations/ ICH guidelines and other international regulatory requirements.
- Experience supporting multiple downstream biotech processes and equipment including protocol (IQ/OQ/PQ) generation and execution.
- Ability to support and drive project success through extreme deadlines.
- Ability to adapt to changing priorities, manage ambiguity, and drive results in a fast-paced environment.
- Strong leadership capabilities.
- Excellent technical writing, review, and analytical skills.
- Ability to organize and manage multiple tasks in a fast-paced environment.
- Excellent communication and interpersonal abilities to effectively collaborate with stakeholders at all levels.
- Proficient in Microsoft Office including Word, Excel, PowerPoint, MS Project, Visio, etc.
- This position is on-site, full-time with the ability to work extended hours when needed during shut down.
- 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.
- 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
- Discounted rate at Anytime Fitness
- Financial Perks and Discounts
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Validation Engineer - Los Angeles, United States - PSC Biotech
Description
Job Description
Job DescriptionPSC 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
We are hiring an experienced and motivated senior-level Validation Engineer to join our team. The Senior Engineer will play a pivotal role in driving the successful execution of projects across the entire lifecycle to support a new facility build-out. The successful candidate should have well-rounded engineering expertise from concept and design, through validation and verification, to release. The ideal candidate will possess a strong track record of managing complex projects, a deep technical skillset, and a commitment to achieving engineering excellence.
Requirements
BenefitsOffering a full suite of benefits, PSC BiotechTM 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.
Estimated annual salary (dependent on experience) $120,000 - $150,000
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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