Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

Job Summary:

The Manager, Technical Unit leads a team that brings diverse skills, competences and knowledge to deliver sustainable results. Drives the Unit to reach goals in Safety, Quality, Delivery, Cost, People development, Customer Satisfaction and Projects, in compliance with current regulations. Coordinates and schedules manufacturing activities delivering production volumes and Unit goals. Promotes the optimization of the unit and a high level of efficiency, by building an operator centric culture, building colleague capabilities and drives continuous improvement in collaboration with the relevant functions. Ensure established GMP's and all other requirements of Thermo Fisher Scientific and Quality systems are met. Typical schedule for this role is Monday through Friday, plus on-call as needed.

Essential Functions

This position is responsible for the end-to-end daily performance of one Steriles manufacturing and filling Technical Unit.

Tasks include maintaining compliance status of area, line optimization (OEE), perform ethnical oversight to ongoing operations, meeting customer commitments and problem solving.

Support the company’s safety program to improve safety awareness and provide a safe work environment. Follow all job-related safety and other training requirements.

Own overall readiness for the Unit activities, the adherence to the production and maintenance short-term schedule, as well as the identification of improvements and efficiencies for medium/long term scheduling.

Take quick action to solve production problems, in compliance with quality standards. Ensure the implementation of TPM principles to increase the reliability and efficiency of equipment, identifying improvement actions and preventative measures to give the optimal output.

The position is the key interaction with customers in the commercial operation of the described lines. Position must also be capable of handling customer and regulatory interactions. Manage the administrative aspects of the group by ensuring the preparation of performance plans, job descriptions, and conducting employee performance reviews. This also includes hiring, rewarding, and disciplining staff as required; providing direction for professional development; maintaining an environment that fosters teamwork; and assigning responsibility and accountability at proper levels. Implements and maintains appropriate training standards for the operations.

Ensure personnel are trained properly. Provide technical training of the employees to increase equipment, technology, and process knowledge.

Participation in Technology Transfer meetings, to gain understanding of the manufacturing process requested by the customer, provide operational insight and approve necessary documentation. Identify risks to production associated with new product introduction. Support the verification of the trends, the gap analysis and corrective actions in respect of budget, customers’ needs, GMPs, procedures and company quality standards.

Champion continuous improvement of the Technical Unit assigned, by proposing improvement actions related to the manufacturing layout and plant flexibility, as well as to the current GMP and costs optimization, in respect of the assigned budget, company interests, procedures and quality standards. Identify and promote cost efficiency and optimization for the Technical Unit. Act to lower variable standard costs when necessary. Prepare expense and headcount budgets. Meet budget targets while providing production operations with adequate resources to meet customer demands.

Qualifications:

Education:

Bachelor’s of Science in Engineering, Chemistry, Microbiology, Pharmacy or related science is strongly preferred.

Experience:

Requires +5 years of operations experience in pharmaceutical manufacturing or related industry is preferred. Equivalent combinations of education, training and relevant work experience may be considered.

Knowledge, Skills, Abilities

Ability to inspire and foster innovation, collaboration, transparency and team effectiveness.

Exceptional Good Manufacturing Practices knowledge.

Demonstrated decision making capabilities.

Strong leadership and conflict resolution skills; ability to delegate tasks.

Demonstrated ability to balance/maintain conflicting goals, responsibilities, and priorities of the organization.

Excellent interpersonal and communication skills, as well as the ability to motivate and lead at all levels

Solid Understanding of Microsoft (MS) Office Applications (Word, Excel, PowerPoint, Share point)

Proficiency with the English language.

Attention to detail and organizational skills. Self-starter, mature, independent, and dependable.

Ability to work in a fast-paced environment under pressure.

Able to identify and implement process improvement initiatives to reduce cost and increase efficiencies in the operations.

Ability to motivate, energize, and retain key staff by direct interactions with supervisors and staff.

Ability to handle and lead professional staff to achieve goals, evaluate and resolve complex technical problems.

Physical Requirements:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

Disclaimer: 

This job description is intended to present the general content and requirements for the performance of this job.  The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.  Managers and supervisors may assign other duties as needed.

Nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.