JOIN OUR TEAM!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.
Essential Duties and Responsibilities:- Development of cleaning revalidation program
- Create cleaning cycle development strategies for a variety of equipment including: process vessels, clean-in-place systems, packaging equipment, parts washers, and production facilities.
- Write validation protocols and reports in support of the site's cleaning validation program
- Investigate and troubleshoot problems which occur during cleaning
- Responsible for planning and execution of onsite cleaning validation programs compliant with the regulatory requirements.
- Prepare and review completed and executed validation packages by compiling and analyzing validation data for submittal for review and approval
- Lead resolution of cleaning deviations through technical knowledge, execution of supporting validation studies, and manufacturing documentation review and approval
- Develops and authors change controls for cleaning process or equipment changes
- Maintain an up-to-date knowledge of validation requirements, practices, and procedures
- Write validation plans and risk assessments related to specific projects and facilities
- Write and review policies and procedures (SOPs)
- Facilitate the development of user requirement specifications and operational SOPs for equipment.
- Perform risk assessment and gap analysis for site cleaning programs.
- Perform cleaning studies, spray coverage testing, cleaning verification swabbing, and risk sampling.
- Leads continuous improvement activities related to cleaning and changeover optimization
- Responsible for identify appropriate facility cleaning/sanitizing agents; participates in cleaning/sanitizing effectiveness studies
- Other duties as assigned
Knowledge and Skill Requirements:- Demonstrated understanding reviewing/writing technical documents, risk assessment reports, validation documents, IOQ protocols and final reports
- Hands-on experience supporting/executing IQ, OQ (IOQ) equipment qualification related to various cleaning processes and activities
- Thorough knowledge of cGMP/FDA regulations
- Ability to drive change and motivate others toward a common vision
- Ability to lead teams that are not direct reports
- Demonstrated facilitation, problem solving, and analytical skills
- Understanding of cGMP regulation and quality management systems for pharmaceutical operations
- Strong communication and presentation skills, both oral and written with a demonstrated ability to present key quality/department/business indicators to both first-line staff and senior management
- Strong interpersonal skills, coupled with attention to detail, excellent review skills and analytical skills
- Must have strong ability to organize and manage multiple tasks in a fast-paced environment.
- Team player
Required Qualifications Bachelor's degree in Engineering or a Scientific field.- 8+ years of experience in a regulated manufacturing industry, medical device, biotechnology or pharmaceutical
- Demonstrated understanding and knowledge of reviewing and writing technical documents such as risk assessments and validation documents
- Strong knowledge of cGMP/FDA regulations
- Strong communication skills (oral and written)
- Ability to organize and manage multiple tasks in a fast pace environment
- Attention to detail
- Demonstrated problem solving and analytical skills
- Strong interpersonal skills/Team Player
- High degree of personal integrity
- Strong computer and mathematical skills
- Self-starter, work without close supervision
PharmaLex is an Equal Opportunity Employer.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.