05 Jun
Lab Commissioning and Validation Scientist
Vacancy expired!
Job Description
Employee Responsibilities:- Perform Commissioning, IQ, OQ and PQ activities for process equipment and utilities. This will include protocol preparation, scheduling, protocol execution, data analysis and authoring final reports.
- Develop/improve validation programs as needed to remain current with cGMPs and industry standards.
- Author and revise a variety of documents (e.g., Batch Records, SOPs)
- Participate in meetings with management, operation and maintenance, design and construction personnel to understand project goals and schedule to ensure commissioning is properly coordinated.
- Serving as validation representative for laboratory instruments and partnering with scientists, quality, and management on implementing new instruments at the site.
- Initiates and leads risk assessment, gap analysis and deviation management for commissioning of laboratory equipment
Qualifications
The Ideal Candidate would possess:- 1-3 years pharmaceutical related experience with degree.
- Validation experience in pharmaceutical processes is preferred.
- Good working knowledge of regulatory requirements
- Experience with laboratory and/or manufacturing instruments/equipment required
- Strong computer, scientific, and organizational skills
- Excellent communication (oral and written) and attention to detail
- Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
- Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
- Bachelor's degree in biology, biochemistry, biotechnology, chemical engineering, or biochemical engineering discipline
- Work will include periodic evening and/or early morning weekday hours as well as weekend hours
- Authorization to work in the United States indefinitely without restriction or sponsorship
Additional Information
Position is full-time, Monday-Friday, 8 a.m.-5 p.m., with overtime as needed. Candidates currently living in a commutable distance to West Point, PA are encouraged to apply.
What we Offer:
Excellent full time benefits including comprehensive medical coverage, dental, and vision options
Life and disability insurance
401(k) with company match
Paid vacation and holidays
Vacancy expired!