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PharmaLex is a highly successful and growing consulting company for the Healthcare industry. PharmaLex offers professional development, training, competitive compensation, plus a stimulating and collaborative work environment. We are committed in providing exciting career opportunities in an atmosphere that values trust, respect, teamwork, creative talent, enthusiasm and diligence.
We are seeking experienced consultants who can provide support as Validation Engineer for a variety of projects. Each qualified candidate will be responsible for coordinating commissioning, qualification and validation activities across all operational areas and ensuring activities are conducted in a timely manner in accordance with cGMP and appropriate regulatory expectations.
REQUIRES IN-DEPTH KNOWLEDGE AND EXPERIENCE:
- Uses best practices and knowledge of internal or external business issues to improve products or services
- Solves complex problems; takes a new perspective using existing solutions
- Works independently and receives minimal guidance
- Acts as a resource for colleagues with less experience
- Competent at risk mitigation for function
TYPICAL MINIMUM EDUCATION AND/OR EXPERIENCE:
- Bachelor’s degree or higher in STEM discipline
- Master’s degree or higher preferred
- 3-5 years of experience in Validation or related discipline
- 1 year GMP experience required or other regulated industry
- Must be able to read and understand English-written job instructions and safety requirements.
COMMON CHARACTERISTICS: A validation engineer’s primary duty is to participate in
- Validation projects relating to biopharmaceutical and pharmaceutical manufacturing equipment, critical computer systems, manufacturing processes and laboratory documentation.
- Responsibilities include coordinating multiple projects, documenting activities via protocols and summary report templates help establish new templates and policies as needed, reviewing facility changes and provide input on re-validation, assessing risks involved in processing steps and related to equipment, developing and/or reviewing validation requirements and design deliverables, partnering with contract validation teams to support and monitor efforts, monitoring validation strategies, ensure polices are followed, conducting validation studies inaccordance with batch records/protocols, and identifying exceptions associated with validation protocol execution.
With a strong Process Validation background. Key areas of expertise and an understanding and/or experience with the following are preferred:
- Technical Transfer
- Process Control Strategies
- Validation Master Plans
- Developing a Process Performance Qualification (PPQ) protocol
- Executing a PPQ protocol
- Mixing Studies
- Hold Studies
- Aseptic processing
- Client interactions (external and internal)
NOTE: Not open for H1B Visa Holder/1099 work arrangement. Only for candidates open for a W2 work arrangement.
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