Director Technology and Engineering
vor 1 Monat
Job Description
Director Technology and Engineering
The Biotech facility, in Schachen, state-of-the-art facility that enables and advances our best work. By integrating leading-edge technology with a dynamic, activity-based workspace, the facility will support seamless connection and collaboration within and across teams and functions. in Schachen Biotech provides Biologics Drug Substance manufacturing for Early Phase Clinical Supply and Technology Innovation implementation into the pipeline.
The Head of Technology and Engineering leads an Operating Unit responsible for New Technology implementation, management of our capabilities roadmap, and subject matter support for batch and continuous manufacturing. The Head of Technology and Engineering leads teams responsible for Process Engineering, Process Automation, and Technology Lifecycle The teams operate within a framework of regulatory compliance and established high standards of Quality, Good Manufacturing Practices (GMP) and Environmental Health & Safety protection. The Head of Technology and Engineering ensures ensures a culture of self-direction, empowerment and accountability, while providing the support necessary to team members working in a widely cross-functional organization.
The primary activities include but are not limited to the following activities:
Leadership
- Sets performance targets in line with business priorities and develops long-term plans for the unit
- Develops the organization and culture (including values and behaviors such as empowerment, diversity and inclusion, accountability, trust, open communication)
- Drives a talent agenda: leads people processes through recruitment, training, coaching and performance management to meet all operational requirements sustaining both global and local competitiveness and diversity
- Establishes robust succession plans for operations and the site. Actively drives talent retention.
- Builds and sustains strong networks in and outside the organization.
- Lead teams responsible for trouble-shooting challenging equipment / automation issues to improve manufacturing performance (e.g. yield improvements, etc.), changes to support new products, and maintaining the automation systems in compliance with cGMP.
Management
- Ensures that all aspects of technical operations within the assigned facilities comply with our policies and standards
- Oversees planning and coordination of Technology and Engineering activities including support of manufacturing, new technology introduction, and maintaining our equipment and automation in a GMP state.
- Designs and operationalizes the platform of capabilities: Process Control, Electronic Batch Records, SU Assembly design
- Manages the allocation of resources (including assets), costs and investments efficiently
- Responsible for the capital investment lifecycle from identification into GMP service.
- Contributes in his/her role within overarching business planning process driving towards fully harmonized technology across sites.
- Identifies and implements continuous improvement initiatives
Required Education, Experience and Skills:
- Bachelor's degree (B.S.) or equivalent in biology, chemical engineering, or a related discipline with at least 12 years or master's degree (M.S.) with at least 10 years previous experience in a relevant position in GMP manufacturing in the pharmaceutical or biotech industry
- Experience in drug substance manufacturing using mammalian cell culture, including upstream and downstream processing
- Proven track record of project management, including execution of large capital expenditure projects
- Experience in Electronic Batch Records / Process Control and leading cross-functional teams.
- Familiarity with DeltaV, PAS-X, S-88 and S-95.
- Working knowledge of cGMP regulations
- Demonstrated experience in managing large multi-level te and leadership skills
- Excellent oral / written communication skills in English (C1), and German (B2)
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
InternationalVISA Sponsorship:
YesTravel Requirements:
Flexible Work Arrangements:
Not ApplicableShift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
08/31/2024*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date:08/31/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R306662
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