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The following areas of responsibility are essential to the satisfactory performance of this position by any incumbent, with reasonable accommodation if necessary. Any nonessential functions are assumed to be included in other related duties or assignments.
Any equivalent combination of education, training, and/or experience that fulfills the requirements of the position will be considered.
Education/Certification/Experience
Skills/Knowledge/Abilities
Full time documented business to business sales experience dependent on level as listed below. Pharmaceutical sales experience preferred. Level of the role will be commensurate to years of experience and performance criteria.
TRAVEL REQUIREMENTS
Regular travel, which may include air travel and weekend or overnight travel
The annual starting salary for this position is between $88,000 – $170,000 annually. Factors which may affect starting salary within this range and level of role may include geography/market, skills, education, experience and other qualifications of the successful candidate.
We offer a competitive benefits package, including:
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
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Technology SME Leader for Sterile and Bio production
The Engineer will provide the overall subject matter expertise on Global level, on a cluster level and on a site level as needed.
Scope of Subject Matter Expert support may include – Standardization processes, Compliance GAP CAP, Reliability improvements, Machine, Facility and Process design and PS, RA processes.
This role can be based in one of our following European based sites, Croatia (Zagreb), Netherlands (Haarlem), United Kingdom (Runcorn), Romania (Bucharest), Lithuania (Vilnius) or Ulm (Germany).
BP scope through the above site processes and monitoring framework, focus but not limited to:
Languages:
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
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The following areas of responsibility are essential to the satisfactory performance of this position by any incumbent, with reasonable accommodation if necessary. Any nonessential functions are assumed to be included in other related duties or assignments.
Any equivalent combination of education, training, and/or experience that fulfills the requirements of the position will be considered.
Education/Certification/Experience
Skills/Knowledge/Abilities
Full time documented business to business sales experience dependent on level as listed below. Pharmaceutical sales experience preferred. Level of the role will be commensurate to years of experience and performance criteria.
TRAVEL REQUIREMENTS
Regular travel, which may include air travel and weekend or overnight travel
The annual starting salary for this position is between $88,000 – $170,000 annually. Factors which may affect starting salary within this range and level of role may include geography/market, skills, education, experience and other qualifications of the successful candidate.
We offer a competitive benefits package, including:
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
These jobs might be a good fit

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This role provides Quality Assurance support to Manufacturing, Supply Chain, and Quality Control Laboratories. Responsibilities include reviewing and approving QA methods, procedures, protocols, investigation documents, and change control documents. The position uses trend and investigational data to improve processes and reduce failures, while representing the quality department on cross-functional teams.
ESSENTIAL AREAS OF RESPONSIBILITY
• Responsible for providing a thorough and timely review and approval of cGMP documents and processes such as those related to deviations, investigations, equipment and facilities Maintenance and calibration, protocols and reports, and facility controls, instruments and procedures.
• Responsible for working with operating departments to facilitate process improvements and lean concepts.
• Responsible for participating in cross functional improvement and process monitoring teams to mitigate unfavorable trends.
• Responsible for providing first response and ongoing QA presence for quality and compliance issues on the manufacturing floor and as needed in the laboratories.
• Responsible for evaluating reports of deviations from defined processes and working with QA to determine if incidents should be escalated to an event investigation.
• Responsible for conducting comprehensive investigations of complex and/or challenging events as assigned.
• Responsible for completing all actions necessary in system to document investigations, identify root causes, create and assign appropriate CAPA’s and gain approval and closure of an event.
• Responsible for investigating critical events, supporting other quality team members in the analysis and documentation.
• Responsible for compiling and maintaining metrics and tracking logs for site’s quality KPI’s or other functions.
• Responsible for supporting activities within electronic systems as needed, such as LIMS, TrackWise, EAM
• Responsible for serving as QA backup as final review/release of production batch records.
• Responsible for completing training requirements and maintaining compliance with all assignments.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s) and Batch Record instructions.
• Responsible for performing additional related duties as assigned.
Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.
Education/Certification/Experience:
• Requires a Bachelor’s Degree or equivalent with a minimum of three years relevant progressive QA experience in the pharmaceutical or a related industry.
• Prefer degree in Science or Engineering.
• Requires experience with and an in-depth knowledge of cGMP and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems.
• Requires experience with the handling of deviations, investigations and CAPA’s.
• Experience with Manufacturing/Quality systems such as Trackwise, Labware, Veeva, Learning Management Systems and statistical software preferred.
• Experience with laboratory related investigations/inquiries preferred.
• ASQ/CQE/CQA Certification preferred.Skills/Knowledge/Abilities:
• Detail oriented with ability to analyze information and create corresponding performance metrics.
• Computer proficiency with comprehensive working knowledge of MS Office products and computer relational databases.
• Ability to demonstrate sound judgment and decision making.
• Ability to build and maintain collaborative relationships between teams, departments and business units.
• Communicate effectively with excellent written and oral communication skills.
• Interact positively and collaborate with co-workers, management and external partners.
• Manage conflict and negotiate resolution.
• Self-directed with ability to organize and prioritize work.
Problem Solving:
• Proactively works on problems of a moderate to complex scope where evaluation of contributing factors requires the analysis of situations or data and an in-depth knowledge and evaluation of various known and unknown factors.
• Seeks out all resources when selecting methods and techniques for obtaining results.
• Acts independently and proactively to recommend and administer methods and procedures for problem resolution.
TRAVEL REQUIREMENTS
• N/A
PHYSICAL REQUIREMENTS:
Frequent:
• Using fingers to perform activities such as picking, pinching or typing.
• Repetitive Motions – frequent motions of the wrists, hands and/or fingers.
• Sitting for extended periods of time.
Occasional:
• Standing for extended periods of time at work station or equipment.
• Walking to move short distances quickly and frequently.
• Grasping – applying pressure to an object with the fingers and palm
• Lifting – raising objects from lower to upper and/or moving objects horizontally – up to 25 lbs.
Visual Acuity:
• Perform activities such as computer work, preparing and analyzing data, extensive reading, visual inspection involving small defects, small parts and/or operation of machines (including inspection), using measurement devices and/or assembly or fabrication of parts at a distance close to the eyes.
WORKING ENVIRONMENT:
• Occasional exposure to moderate to loud noise levels.
• Occasional exposure to moving mechanical parts or equipment.
• Occasional exposure to fumes, odors, dusts, mists, gasses or vibrations.
• May be required to wear personal protective equipment (PPE) as needed when in production areas (i.e. safety glasses, respirator, hearing protection, gloves, etc.).
We offer a competitive benefits package, including:
• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
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This position can be based in the US (Parsippany), the Netherlands (Haarlem) or the UK. (In the UK, it can be based remotely.)
TRAVEL REQUIREMENTS Approximately up to 20% travel to support key meetings and cross-functional planning.
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
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ESSENTIAL AREAS OF RESPONSIBILITY
• Responsible for providing a thorough and timely review/approval or author/execution of cGMP documents and processes such as those related to deviations, investigations, equipment and facilities maintenance and calibration, protocols and reports, and facility controls, instruments, and procedures.
• Responsible for working with operating departments to facilitate process improvements and lean concepts.
• Responsible for leading cross functional improvement and process monitoring teams to mitigate unfavorable trends.
• Responsible for providing first response and ongoing QA presence for quality and compliance issues on the manufacturing floor and as needed in the laboratories.
• Responsible for evaluating reports of deviation from defined processes and working with QA to determine if incidents should be escalated to an event investigation.
• Responsible for conducting comprehensive investigations of critical, complex and/or challenging events as assigned.
• Responsible for serving as QA lead on research and development products and related document reviews/approvals – including change control items, protocols, batch records and deviations as applicable and product disposition.
• Responsible for working with the laboratory to investigate OOT and OOS events, providing feedback and manufacturing information.
• Responsible for compiling and maintaining metrics and tracking logs for site’s quality KPI’s or other functions.
• Responsible for supporting internal/external, scheduled and unscheduled audits of operational areas.
• Responsible for supporting activities within electronic systems as needed, such as LIMS, TrackWise, EAM.
• Responsible for serving as QA backup for final review/release of production batch records, managing the site change control system and for validation/qualification protocols and related activities.
• Responsible for completing training requirements and maintaining compliance with all assignments.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s) and Batch Record instructions.
• Responsible for performing additional related duties as assigned.
Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.
Education/Certification/Experience:
• Requires a Bachelor’s Degree or equivalent with a minimum of seven years relevant progressive QA experience in the pharmaceutical or a related industry.
• Prefer degree in Science or Engineering.
• Preferred experience in a solid dose manufacturing environment.
• Requires experience with and an in-depth knowledge of cGMP and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems.
• Requires experience with the handling of deviations, investigations and CAPA’s.
• Experience with managing partner relationships preferred.
• Experience with Manufacturing/Quality systems such as Trackwise, Labware, Veeva, Learning Management Systems and statistical software preferred.
• Experience with laboratory related investigations/inquiries preferred.
• ASQ/CQE/CQA Certification preferred.Skills/Knowledge/Abilities:
• Detail oriented with ability to analyze information and create corresponding performance metrics.
• Computer proficiency with comprehensive working knowledge of MS Office products and computer relational databases.
• Ability to demonstrate sound judgment and decision making.
• Ability to build and maintain collaborative relationships between teams, departments and business units.
• Motivate, influence and lead others with and/or without direct supervisory authority.
• Communicate effectively with excellent written and oral communication skills.
• Interact positively and collaborate with co-workers, management and external partners.
• Manage conflict and negotiate resolution.
• Self-directed with ability to organize and prioritize work.
• Project management and advanced presentation skills preferred.
Problem Solving:
• Proactively works on problems of a moderate to complex scope where evaluation of contributing factors requires the analysis of situations or data and an in-depth knowledge and evaluation of various known and unknown factors.
• Seeks out all resources when selecting methods and techniques for obtaining results.
• Acts independently and proactively to recommend and administer methods and procedures for problem resolution.
TRAVEL REQUIREMENTS
• N/A
PHYSICAL REQUIREMENTS:
Frequent:
• Using fingers to perform activities such as picking, pinching or typing.
• Repetitive Motions – frequent motions of the wrists, hands and/or fingers.
• Sitting for extended periods of time.
Occasional:
• Standing for extended periods of time at work station or equipment.
• Walking to move short distances quickly and frequently.
• Grasping – applying pressure to an object with the fingers and palm
• Lifting – raising objects from lower to upper and/or moving objects horizontally – up to 25 lbs.
Visual Acuity:
• Perform activities such as computer work, preparing and analyzing data, extensive reading, visual inspection involving small defects, small parts and/or operation of machines (including inspection), using measurement devices and/or assembly or fabrication of parts at a distance close to the eyes.
WORKING ENVIRONMENT:
• Occasional exposure to moderate to loud noise levels.
• Occasional exposure to moving mechanical parts or equipment.
• Occasional exposure to fumes, odors, dusts, mists, gasses or vibrations.
• May be required to wear personal protective equipment (PPE) as needed when in production areas (i.e. safety glasses, respirator, hearing protection, gloves, etc.).
We offer a competitive benefits package, including:
• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
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The Physiochemical Testing group strives to deliver creative medicines to patients through performance fundamental chemical, physical and structural testing within a GxP-compliant QC laboratory to support preclinical and clinical production as well as commercial launch. Primary responsibilities center on being able to develop, implement and manage departmental strategies for physiochemical testing with respect to product in-process, release and stability testing, raw materials testing, contract lab testing, and regulatory submissions. The incumbent may also participate in/provide oversight of activities related to the management of CGMP analytical method lifecycle (e.g. management of reference standard, assay control, critical reagents and materials, product specification and sampling plan processes). The incumbent should possess a practical understanding of bio-pharmaceutical drug development and GxP requirements as knowledge of local, regional and global regulatory compliance (ICH, GMP, EPA, OSHA, DEA, etc.) are integral responsibilities of this position.
Overseeing QC laboratory operations by managing a team of professionals and junior managers who execute physiochemical CGMP testing.
Establishing and maintaining strategies for method and/or process implementation, continuous improvement initiatives, and method transfer and validation processes.
Developing strategies and approaches for special studies, as applicable.
Ensuring compliance with applicable ICH, GxP and safety regulations as an individual contributor as well as an educator and manager of junior staff. Executional tasks include but are not limited to:
• Supporting general GxP and data integrity compliance in both routine and non-routine work activities for both internal and external contract lab testing. This includes efforts as an individual contributor that may include but are not limited to the review and approval of data in raw and reported forms as well as training staff in compliance or technical principles
• Providing oversight and/or support of QC lab investigations, audits, inspections, and communications with regulatory agencies and health authorities
• Providing support for staff who identify, write, revise, manage and implement standard operating procedures, work instructions, standard practices, protocols, and reports. Executing these tasks as an individual contributor, as applicable
Engaging, coaching, motivating and empowering staff to ensure their skills match their roles and to continually develop, thereby improving productivity and efficiency of the department operations.
Education
Minimum: BS/MS in relevant discipline
Preferred: PhD in Biochemistry, Analytical Chemistry
Experience
10-15+ years (BS/MS/PhD) in the (Bio)pharmaceutical industry with deep technical knowledge in physiochemical testing applications and one or more areas of drug development
Specialized Knowledge:
LIMS, TrackWise or VEEVA Quality Management Systems, Documentum Based Systems
We offer a competitive benefits package, including:
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
Important notice to Employment Agencies - Please Read Carefully
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The following areas of responsibility are essential to the satisfactory performance of this position by any incumbent, with reasonable accommodation if necessary. Any nonessential functions are assumed to be included in other related duties or assignments.
Any equivalent combination of education, training, and/or experience that fulfills the requirements of the position will be considered.
Education/Certification/Experience
Skills/Knowledge/Abilities
Full time documented business to business sales experience dependent on level as listed below. Pharmaceutical sales experience preferred. Level of the role will be commensurate to years of experience and performance criteria.
TRAVEL REQUIREMENTS
Regular travel, which may include air travel and weekend or overnight travel
The annual starting salary for this position is between $88,000 – $170,000 annually. Factors which may affect starting salary within this range and level of role may include geography/market, skills, education, experience and other qualifications of the successful candidate.
We offer a competitive benefits package, including:
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
These jobs might be a good fit