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- Monitoring the equipment, equipment status and equipment performance to ensure production quantities and quality/safety. Initiate corrective actions in case of deviations in quantity, quality and safety.
- Author qualification documents such as (Validation Plan (VP), Users Requirement Specifications (URS), Design and Configuration Specification (DACS) Installation/Operation Qualification IOQ, Performance Qualification (PQ), Final report and Requirement Traceability Matrix (RTM).
- Develop and execute validation process and studies that are compliant with established procedures and aligned with regulatory requirements and industry best practices. As needed perform technical qualification of existing and new equipment
- Prepare and supervise routine repair and maintenance activities, including major shutdowns. Preparation of checklists, plans, etc.
- Coordination of service companies regarding approval of work steps and on-site inspections
- Develop, author, maintain and conduct , standard operating procedures, risk assessment, change controls, CAPA, Quality Incidents and deviations.
- Perform regular inspections to ensure continuous EHS and GMP compliance of the facilities.
- Assist in the planning and prioritization of development and production projects. Assist in the planning of new facilities. Manage internal engineering projects
- Support the Director of Plant Engineering in the planning and coordination of investments (CAPEX planning, etc.) of the department.
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Plant Engineer III - San Diego, United States - Wacker Chemie AG
Description
Do you want to take responsibility and make a difference with your work? With your expertise, we can achieve great goals together.
As one of the world's most research-intensive chemical companies, we've been making countless products that are an integral part of your everyday life possible for over 100 years.
From vegan food to resource-efficient buildings to solar cells, we develop sustainable solutions that change the future.To strengthen our team in San Diego,we are looking for you as a(n) Plant Engineer III.Wacker Biotech is seeking a highly organized and motivated team member to join our Plant Engineering Team.
The position reports to the Sr.Manager of Plant Engineering and serves as a subject matter expert in the facilities operation, maintenance and qualification of Wacker Biotech US's GMP facility and equipment.
This position will work closely with other functional team leaders and associates to ensure the operation of validated environment(s) according to GMP and other regulatory requirements.
Wacker is a safety-first culture, the Plant Engineer III will be responsible in maintaining a safe work environment, following all safety rules and wearing appropriate PPE when needed.
Identifying any potential safety issues and reporting such issues and assist in rectifying, if applicableEssential Functions:Position Requirements:
Bachelor's degree in engineering (mechanical, electrical, or related field)
Minimum of 5 years of direct facilities and engineering, building operations or facilities management experience in the biotechnology or pharmaceutical industry.
Prior experience with cGMP requirements Ability to work successfully with all team members in a fast-paced environment Excellent written and verbal communication skills, including the ability to interact effectively with technical experts and non-technical stakeholders Experience and ability to work optimally in a multi-tasking team and fast pace environment, with skills on prioritizing, delivery and being flexible in response to change Ability to provide expert advice and clear recommendations, and to propose insights and develop solutions to sophisticated problemsThe anticipated salary range for candidates who will work in San Diego is $81, , The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc .
Wacker is a multi state employer and this salary range may not reflect positions that work in other states.What do we offer? WACKER is an equal opportunity employer committed to diversity, equity, inclusion, and sustainability. We are innovators, researchers, and pioneers and we believe that our individual differences are our collective strength. We foster an inclusive environment that promotes individuality, celebrates diversity, and builds cohesive teams.
Together, we create exceptional value for our employees, our customers, and our communities by creating a culture of inclusion and equity that enables, empowers, and values our diverse contributions.
WACKER strives to reward its employees in a fair and equitable manner.Our Total Rewards Package considers employee wellbeing and is comprised of compensation, benefits, work-life balance, performance & recognition, and career development.
Compensation and Incentive plans Medical, Dental, and Vision Insurance effective day 1 Paid Time Off in addition to personal days and holidays Paid parental leave Wellbeing fund Flexible hybrid work arrangements 401(k) with company match Education Assistance Program Career development and advancement opportunities Support for Community Involvement We are looking forward to your online application at Code: 26861 #LI-CE1The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job.
A minimum requirement for this US-based position is the ability to work legally in the United States on a permanent unrestricted basis.
Visa sponsorship is not available for this position, including for any type of US permanent residency (e.g., for a green card).WACKER is proud to be an Equal Opportunity/Affirmative Action Employer, making decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability, or any other protected class.
