Validation Engineer at PharmaLex

Makati, Metro Manila, Philippines -

Full Time

Start Date

Immediate

Expiry Date

02 Apr, 26

Salary

0.0

Posted On

02 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Validation Engineering, Regulatory Compliance, Computer Validation, FDA Regulations, Validation Plans, IQ Protocols, OQ Protocols, PQ Protocols, GMP Systems, GCP Systems, GLP Systems, Automated Testing Tools, ERP Software, Communication Skills, Team Collaboration, Client Interaction

Industry

Pharmaceutical Manufacturing

Description

Arbour Group LLC (a Cencora PharmaLex company) is a global leader in regulatory compliance products and services for the pharmaceutical, medical device, and biotechnology industries. Regulatory compliance is a mission-critical component of business risk management and a key performance indicator for the companies we serve. Our approach has successfully assisted over 150 multinational companies in complying with both domestic and international authorities in a timely and cost-effective manner. Visit us on the web at www.arbourgroup.com. We are looking for full-time Validation Engineers to add to our Validation Services team. Responsibilities can include the development, execution, and management of computer validation activities in accordance with the client’s policies, standards, and regulatory expectations. Knowledge, Skills, and Experience Required: Bachelor’s Degree 2+ years of experience in Medical Device, Biotechnology and/or Pharmaceutical compliance, validation, manufacturing and engineering Knowledge of FDA-regulated IT systems or Life Sciences Compliance is a must Experience developing validation plans, developing and executing IQ, OQ, PQ protocols. Providing guidance and support for regulatory compliance issues Solid understanding of regulatory compliance requirements 21 CFR Part 11 Development, testing and validation of regulated computerized cGMP, GCP and/or GLP systems Experience with automated testing tools and ERP packaged software We are seeking candidates with strong verbal and written communication skills, and a positive team and client interaction.Ideal candidates will have a combination of experience in information systems, computer validation, software quality assurance, and ERP implementation. Open to candidates seeking both employee and contract positions. What's on Offer? Work in a company with a solid track record of performance. Have a hybrid or remote working arrangement, on top of a competitive salary offer and employment benefits granted upon employment start date. Have the opportunity to work with a diverse team and collaborate with different industry experts and SMEs internationally. Don't miss this amazing opportunity to grow your career in a global organization while contributing to both people and process excellence. Apply Now! We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, creed, national origin, ancestry, sex, age, handicap or disability, marital status, sexual orientation, gender identity or expression, pregnancy or pregnancy-related condition, genetic information, veteran status, immigration or citizenship status, military obligations, status as a domestic violence victim or a victim of sexual assault or stalking, participation in discrimination complaint-related activities, or any other status protected under applicable federal, state or local law.

Responsibilities

The Validation Engineer will develop, execute, and manage computer validation activities according to client policies and regulatory expectations. This role involves providing guidance on regulatory compliance issues.